Summary

On 21 February 2020 a drug trial was commenced to trial remdesivir versus placebo for the treatment of covid. The initial report was published on 22 May 2020, and the final report on 5 November 2020.

The opening paragraph states, "Although several therapeutic agents have been evaluated for the treatment of coronavirus desease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.”

The primary outcome was to assess “time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only”. Assessment of mortality was NOT an objective of this drug trial, which is noteworthy in consideration of the fact that 3 months earlier Fauci’s published drug trial results following the ebola drug trials reported a death rate of 53.1% in remdesivir.

The November 2020 report states: “Fifty-two patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death and 10 withdrew consent…. Fourteen patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29.”

Results

The report claims “remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection”, and further states the primary outcome was “median, 10 days, as compared with 15 days”. In other words, it was claimed the “benefit” of remdesivir is that it reduced hospital time by 5 days.

On 30 April 2020, this benefit of 5 day reduced hospital time was globally promoted by Anthony Fauci who said, “remdesivir has a clear-cut significant positive effect in diminishing the time to recovery”, and “what it is proven is that a drug can block this virus.” Click here to watch Anthony Fauci promotion.

The World Health Organisation [WHO] rejected this claim in November 2020, when it globally announced remdesivir offered little or no benefit.

Other drug trials also contradict Fauci’s claim, and report remdesivir has not been found to be efficacious.

Of significance is that mortality was not assessed in this drug trial, despite:

1. occurances of death in the remdesivir group; and

2. the December 2019 mortality statistics of 53.1% for remdesivir.

Trial Start Date: 22 March 2020

Trial End Date: 4 October 2020

Date of First Report: 2 December 2020

Updated Report: 11 February 2021

Number of patients in remdesivir drug trial: 11,330

Number of patients who received remdesivir: 2,750

Deaths: 12.5%

Trial Start Date: 25 January 2020

Trial End Date: 7 March 2020

Date of First Report: 10 April 2020

Number of patients in remdesivir drug trial: 53

Locations: USA, Europe, Canada & Japan

Deaths in non ventilated patients: 13%
Deaths in ventilated patients: : 18%

Adverse events: 60%
Serious adverse events: 23%

Summary

Methods

The report states, “Remdesivir was given on a compassionate-use basis to patients hospitalised with Covid-19.”

Patients were given a 10 Day course of remdesivir. A total of 1100mg of remdesivir was given: 200mg on Day-1 and 100mg each day thereafter.

61 patients were enrolled. Due dosing errors and/or defective data, only 53 patients’ data was analysed in this trial.

Results

The report states of the 53 patients analysed:

• 25 patients were discharged;

• 7 patients died;

• 6 patients died who received invasive ventilation; and

• 1 patient died who did not receive invasive ventilation.

The report does not state the outcome of the remaining 14 patients.

Safety [Dangers]

The report states adverse events were more common in patients receiving invasive ventilation, with 32 patients [60%] having adverse events including:

• increased hepatic enzymes (indicates inflammation or damage to cells in the liver);

• diarrhea;

• rash;

• renal impairment (kidneys no longer function properly);

• hypotension (low blood pressure).

Further, 12 patients [23%] had serious adverse events including:

• multiple-organ-dysfunction syndrome (heart, lung, liver, or kidney failure where artificial support usually becomes necessary to sustain life);

• septic shock (life-threatening condition when blood pressure drops to a dangerously low level);

• acute kidney injury (sudden damage of kidneys);

• hypotension (low blood pressure).

Conclusion

The report claims 36 patients showed clinical improvement, yet the results state only 25 patients were discharged.

Further, the report says, “Measurement of efficacy will require ongoing randomized, placebo controlled trials of remdesivir therapy [Funded by Gilead Sciences]. In other words, Gilead, the owner of the drug remdesivir, was unable to provide any clear or definitive conclusion on its drug.

Discussion

The report says, “To date, no therapy has demonstrated efficacy for patients with Covid-19. This preliminary report describes the clinical outcomes in a small cohort of patients who were severely ill with Covid-19 and were treated with remdesivir. Although data from several ongoing randomized, controlled trials will soon provide more informative evidence regarding the safety and efficacy of remdesivir for Covid-19, the outcomes observed in this compassionate-use program are the best currently available data. Specifically, improvement in oxygen-support status was observed in 68% of patients, and overall mortality was 13% over a median follow-up of 18 days.”

Commentary

It is difficult to understand how a drug that in December 2019 was reported to result in a 53% death rate and rejected to treat ebola, was deemed appropriate to be given to hosptialised patients just one month later in January 2020 under “compassionate” reasons to treat covid.

In other words, a drug with a documented high mortality rate was given to patients to treat covid.

On the premise the mortality occurred in both this drug trial and the ebola drug trial:

• How were covid death determined?

• Did death occur as a consequence of remdesivir, or the virus?

• Why have covid deaths only been attributed to the virus, when the drug remdesivir is documented to result in 53% death, and the drug owner Gilead reports it causes serious adverse events such as acute kidney injury, multi organ failure, etc.

Statistics

The overall results must be considered against the fact the report states all 53 patients did not receive the full 1100mg dosage of remdesivir:

• 75% received the full 10-day course of remdesivir (1100mg)

• 19% received 5 to 9 days of treatment; (600mg to 1000mg) and

• 6% received fewer than 5 days of treatment (200mg - 600mg).

The mortality rate of 13% and serious adverse events of 23% reported therefore must be considered against the fact that 25% of patients did not receive the full treatment of remdesivir.

As such, it would be reasonable to conclude that mortality and adverse events statistics would be higher if 100% of patient received 100% of the treatment dosage of 1100mg of remdesivir.

Outcome

Based on the fact Gilead stated that, “no therapy has demonstrated efficacy” (at the date of publication of this drug trial), means Gilead admitted remdesivir was not efficacious in treating covid.

Gilead did demonstrate a long list of serious adverse events in patients who received remdesivir.

Trial Start Date: 6 March 2020

Trial End Date: 26 March 2020

Date of Report: 16 May 2020

Number of patients in remdesivir drug trial: 397

Location of Drug Trial: 55 Hospitals in USA, Italy, Spain, Germany, Hong Kong, Signapore, South Korea & Taiwan

Death: 8% in 5-Day Group
Death: 11% in 10-Day Group

Adverse Events: 70% in 5-Day Group
Adverse Events: 74% in 10-Day Group

Serious Adverse Events: 21% in 5-Day Group
SeriousAdverse Events: 35% in 10-Day Group

Summary

Drug trial by remdesivir owner Gilead Sciences in which patients with severe COVID-19 were trialled with either a 5-day or 10-day course of remdesivir.

This report opens with Gilead’s claim remdesivir “is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease.”

Methods

397 patients were analysed in the trial, with the objective being the clinical status at day 17:

• 200 were given a 5 day remdesivir treatment (total of 600mg of remdesivir - 200mg on Day 1 plus 100mg each day thereafter);

• 197 patients were given a 10 day remdesivir treatment (total of 1100mg of remdesivir - 200mg on Day 1 plus 100mg each day thereafter).

Results

The report states, “At baseline, patients assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group.”

Safety [Dangers]

The report states most common adverse events were :

• nusea 9%;

• worsening respiratory failure 8%;

• elevated alanine amino-transferase level 7%;

• constipation 7%.

Conclusion

In its conclusion, the report says, “In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined.”

Discussion

Gilead stated that due to the fact the trial was done without a placebo, the trial “was not to test the efficacy of remdesivir”.

Commentary

Gilead’s claim of antiviral efficacy was arrived at on “animal models” - therefore it is a concept. Antiviral efficacy was therefore not arrived at as a consequence of testing the real virus on a real human.

Results

The fact the report states patents who received 1100mg of remdesivir on the 10-day treatment were “significantly worse clinical status”, remdesivir is more toxic in increased amounts.

Statistics

The overall results must be considered against the fact the report states all 397 patients did not receive their full dosage of remdesivir:

• 86% received the full 5-day course of remdesivir (600mg)

• 0% in10-day group were given the full dosage of remdesivir; (1100mg). 44% “completed the course of treatment for a median duration of 9 days”.

The mortality rate of and serious adverse events reported must be considered against the fact that patients did not receive the full treatment of remdesivir.

As such, it would be reasonable to conclude that mortality and adverse events statistics would be higher if 100% of patient received 100% of the treatment dosage of remdesivir.

Conclusion

Gilead admitted it failed to demonstrate a benefit from remdesivir following this drug trial. Further, Gilead stated the report was not even to test remdesivir for efficacy.

Gilead did demonstrate the very high rate of adverse events, and serious adverse events with remdesivir.

It is difficult how remdesivir became global hospital treatment based on:

• Gilead failed to prove efficacy;

• Remdesivir’s death rates; and

• High rate of adverse and serious adverse events.

Trial Start Date: 15 March 2020

Trial End Date: 18 April 2020

Date of Report: 21 August 2020

Number of patients in remdesivir drug trial: 584

Location of Drug Trial: 55 Hospitals in USA, Italy, Spain, Germany, Hong Kong, Signapore, South Korea & Taiwan

Death: 1% in 5-Day Group
Death: 2% in 10-Day Group

Adverse Events: 51% in 5-Day Group
Adverse Events: 59% in 10-Day Group

Summary

Drug trial by remdesivir owner Gilead Sciences in which patients with moderate COVID-19 were trialled with either a 5-day or a 10-day course of remdesivir compared to standard care.

Methods

397 patients were analysed in the trial, with the objective being the clinical status at day 17:

• 199 were given a 5 day remdesivir treatment (total of 600mg of remdesivir - 200mg on Day 1 plus 100mg each day thereafter);

• 197 patients were given a 10 day remdesivir treatment (total of 1100mg of remdesivir - 200mg on Day 1 plus 100mg each day thereafter).

Results

The report stat

Safety [Dangers]

The report shows in both 5 and 10 day groups, adverse events occurred in greater than 50% of patients. Adverse events, include but are not limited to:

• Hypokalaemia - 7% (electrolyte abnormality in hospitalised patients, mostly caused by drugs).

• Alanine aminotransferase - (ALT) - 32% (is increased with liver disease).

• AST (aspartate aminotransferase): 32% (Cells that contain AST are damaged. AST is released into blood. Causes liver and other organ damage).

• Creatinine clearance decrease: 25% - demonstrates kidney disease.

Conclusion

The report concludes outcome of remdesivir:

• 10 Day Course: did not have a statistically significant difference in clinical status compared with standard care at 11 days.

• 5 Day Course: had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.

In other words, remdesivir had in effect the same outcome as patients who did not receive any drugs to treat covid.

Commentary

Gilead’s testing and claim of efficacy was done on “models”, and is therefore a concept. Its claim of efficacy was therefore not arrived at as a consequence of testing the real virus on a real human.

Results

The fact the report states patents who received 1100mg of remdesivir on the 10-day treatment were “significantly worse clinical status”, remdesivir is more toxic in increased amounts.

Statistics

The objective of the drug trial was clinical status on day 11, however:

• of the 199 enrolled 5 day remdesivir :
  - 191 started the treatment;
  - 46 stopped the treatment: and
  - only 145 completed the treatment

• of the 197 enrolled a 10 day remdesivir treatment:
  - 193 started the treatment;
  - 120 stopped treatment: and
  - only 73 completed the treatment

Of concern is the reported percentages of adverse events. Table 3 in the report provides an adverse event summary, however “percentages” are calculated according to the number of patients participating in the group, ie the 10-day group had 193 patients. However 120 patients stopped the treatment, leaving 73 patients in that group. Therefore, the calculations according to the total number that commenced the trial, rather than the number that completed the trial, greatly distorts the outcomes in a falsely favourable manner for remdesivir.

Conclusion

Gilead admitted it failed to demonstrate a benefit from remdesivir following this drug trial.

Trial Start Date: 6 February 2020

Trial End Date: 12 March 2020

Date of Report: 16 May 2020

Number of patients in remdesivir drug trial: 237

Location of Drug Trial: Hubei, China

Deaths 14%
Adverse Events: 66%

Summary

The report opens with a paragraph that says, “No specific antivirual drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19).” Therefore, at the time of publication of this report, 16 May 2020, it was determined that no drugs were found to be effective against covid.

Methods

The primary outcome of this drug trial was, “time to clinical improvement up to day 28” and consisted 237 patients:

• 157 remdesivir.

• 79 placebo

Remdesivir was given as part of a 10 day treatment (total of 1100mg of remdesivir - 200mg on Day 1 plus 100mg each day thereafter).

Safety / Dangers

Adverse events were reported in 102 patients [66%] of 155 remdesivir recipients. Further, remdesivir was ceased early because of 18 (12%) of serious adverse events.

Serious adverse events:

• Respiratory failure or acute respiratory distress syndrome 10% (life-threatening condition characterized by poor oxygenation)

• Cardiopulmonary failure 5% (cessation of adequate heart function and respiration and results in death without reversal);

• Cardiac arrest 1% (heart stops beating suddenly)

• Septic shock 1% ((life-threatening condition when blood pressure drops to a dangerously low level);

• Thrombocytopenia 1% (low blood platelet count)

• Haemorrhage of lower digestive tract 1% (hemorrhoids);

• Deep vein thrombosis 1% (blood clot forms in one or more of the deep veins in the body);

• Multi-organ dysfunction 1% ((heart, lung, liver, or kidney failure where artificial support usually becomes necessary to sustain life);

Adverse events:

• Hypoalbuminaemia 13% (raised globulin suggests presence of liver disease);

• Hypokalaemia 12% (common electrolyte abnormality in hospitalised patients, mostly caused by drugs);

• Increased blood glucose 7% [high blood sugar];

• Anaemia 12% (deficiency in number or quality of red blood cells);

• Rash 7%;

• Thrombocytopenia 10% (low blood platelet count)

• Increased total bilirubin 10% (High levels of bilirubin means liver is not functioning correctly)

• Increased blood lipids 6% (excess amount of blood lipids can cause fat deposits in artery walls, increasing risk for heart disease)

• Increased white blood cell count 7% (increased production of white blood cells to fight an infection)

• Hyperlipidaemia 6% (abnormal level of total cholesterol);

• Increased blood urea nitrogen 6% (means kidneys are not working well);

• Increased neutrophil 6% (result of a bacterial infection);

• Aspartate aminotransferase increased 5%

• Constipation 14%;

• Nausea 5%';

• Diarrhoea 3%;

• Vomiting 3%;

• Reduced serum sodium 3% (occurs when you have an abnormally low amount of sodium in your blood or when you have too much water in your blood);

• Increased Serum potassium 3% (kidney disease means kidneys cannot remove extra potassium).

Conclusion

The report states, “In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits”.

Commentary

The drug trial opened stating no antiviral drugs were effective and concluded stating remdesivir was not found to provide any benefit.

The report summary says the dose regime of intravenous remdesivir was adequately tolerated but did not provide significant clinical or antiviral effective in seriously ill patients with covid.

In short, remdesivir does nothing benefitical.

Conclusion

Remdesivir does however result in a long list of adverse events and serious adverse events.

It is unreasonable to accept that any person would agree to be adminsitered remdesivir on the facts of the drug.

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Trial Start Date: 28 March 2020

Trial End Date: 4 October 2020

Publication Date: 31 July 2021

Number of patients in remdesivir drug trial: 181

Location of Drug Trial: 23 Hospitals in Norway

Death: 6.6%

Summary

This report opens with the paragraph, “The World Health Organisation [WHO] Solidarity trial showed no effect of remdesivir or hydroxychloroquine (HCQ) on mortality, but the antivirual effect of these drugs are not know”.

Method

The objective of this drug trial was to evaluate the effects of remdesivir and hydroxychloroquine on:

1. all-cause, in-hospital mortality;

2. the degree of respiratory failure and inflammation; and

3. viral clearance of clinical follow up.

A total of 181 patients were divided into the following treatment groups:

• 42 patients received remdesivir;

• 52 patients received hydroxychloroquine; and

• 87 patients received standard of care.

Safety / Dangers

Adverse events, including but not limited to:

• Respiratory, thoracic and mediastinal disorders 14.3%

• Cardiac disorders 4.8%

• Gastrointestinal disorders 7.1%

• Nervous system disorders 1.1%

• Skin and subcutaneous tissue disorders 4.8%

• Vascular Disorders 2.4%

Serious adverse events, including but not limited to:

• Respiratory, thoracic and mediastinal disorders 11.9%

• Cardiac disorders 4.8%

• Gastrointestinal disorders 2.4%

• Nervous system disorders 2.4%

Conclusion

The report states, “No significant differences were seen between treatment group in mortality during hospitalisation.”

Further the report states, “Neither remdesivir nor hydroxychloroquine affected viral clearance in hospitalized patients with covid-19”, and “no significant antiviral effects of remdesivir or hydroxychloroquine …”

The conclusion states, “Neither remdesivir nor HCQ affected viral clearance in hospitalized patients with COVID-19.”, and “In conclusion, the overall lack of effect of remdesivir and HCQ on the clinical course of patients hospitalized for COVID-19 was accompanied by a paucity of effect on SARS-CoV-2 firal clearance in the orophpharynx.

Our findings question the antiviral potential of these drugs in hospitalized patients with COVID-19.”

Commentary

Another drug trial that its opening statement says no antiviral drugs were effective and concluded stating the antiviral effect was not known.

In short, remdesivir offers nothing benefitical.

Conclusion

The report did report further adverse events that are not listed in other drug trials.

Again, another report that shows a long list of adverse events and serious adverse events, yet zero benefits.

Summary

Opening paragraph says, “The antiviral efficacy of remdesivir against SARS-CoV2 is still contraversial. We aim to evaluate the clinical efficacy of remdesivir plus standard of care complated with standard of care alone in patients admitted to hospital with COVID-19, with indication of oxygen or ventilator support”.

Remdesivir group included 429 patients and standard of care 428 patients.

Findings states, “No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19”, and “Remdesivir administration was well tolerated but was neither associated with a better clinical outcome at day 15 and 29 nor with a faster viral clearance.”

Adverse events, including but not limited to:

1. Acute kidney injury 6%.

2. Acute renal failure 1%.

3. Acute respiratory distress: 9%.

4. Acute respiratory failure: 7%.

5. Sepsis 1%.

6. Arthythmia 2%.

7. Pulmonary embolism 2%.

Click link to view copy of the report’s list of adverse events : Adverse Events.

Summary

Drugs in Context provided an overview of several remdesivir drug trials, including. The reviewed trials are provided on this website.

CONCLUSION

A chief concern remains: there are no antiviral treatments proven to be effective in fully published, peer-reviewed, randomized placebo-controlled trials.

Summary

The report says, “This review is specifically aimed to summarize available evidence and ongoing clinical trials of remdesivir as a potential therapeutic option for COVID-19…. Several studies showed that remdesivir had promising in vitro and in vivo antiviral activities against SARS-CoV-1 and MERS-CoV-2 strains. On the top of this, it exhibited a promosing in vitro activity against SARS-CoV-2 strains, though there are no published studies that substantiate its activity in vivo until the time of this review.”

CONCLUSION

The report says, “Despite promising effects of remdesivir against previous beta-coronaviruses as well as the current novel coronaviruses in vitro there is no published in vivo study that substantiates the in vitro activities against this global public health threat.

A case report and observational studies are not sufficient to generate an evidenced-based medicine on the clinical use of remdesivir for this pandemic.

A double blind, placebo controlled randomized clinical trial showed that remdesivir did not have statistically significant clinical benefit in reducing the time to clinical improvement in severe COVID-19 patients compared to placebo.

Though remdesivir is readily available for a compassionate use in many countries, it is imperative to wait the remaining ongoing clinical treials to justify its clinical utility on larger cohort of COVID-19 patients.”

NO DRUG TRIAL OR REPORT HAS BEEN PUBLISHED TO EVIDENCE REMDESIVIR HAS A CLINICAL BENEFIT.

Summary

This report compares results in animals and then results in humans. In each case no adverse events are found in rats, monkies etc, yet do occur in humans. Based on the fact remdesivir was developed in about 2014, and was thoroughly trialled in 2018 and 2019 in humans as part of four drugs trialled to treat ebola, it is interesting data on animals is even considered in 2020.

The report says, “There is an urgent demand for safe and effective therapeutics. Remdesivir, a broad-spectrum antiviral drug, emerges as a potential candidate for fighting against COVID-19 because of its potent in vitro anti-SARS-CoV-2 activity and encouraging benefits for the infected patients. However, with increasing application, adverse effects of remdesivir have been detected and become a concern of clinicians. Since current safety data about remdesivir is fragmented and limited, we reviewed published studies and official documents regarding remdesivir treatment and summarize the up-to-date safety information.”

• Hepatotoxicity [Liver Damage]: Toxicity studies of remdesivir in animals showed no liver changes, while transient treatment-emergent elevations in aminotransferases were noticed in clinical studies of remdesivir. According to Grein et al.’s study on compassionate-use remdesivir against COVID-19 [see Drug Trial 3 above], 23 % of the patients reported increased hepatic enzymes.

• Gastrointestinal Symptoms: Diarrhea was observed in 9% of the remdesivir recipients in Grein et al.’s study [see Drug Trial 3 above].

• Respiratory toxicity. Acute respiratory distress syndrome (4%) and pneumothorax (4%) were reported after the infusion of remdesivir in Grein et al.’s study [see Drug Trial 3 above]. Based on the findings from a RCT in China, more patients in the remdesivir group (10%) than the placebo group suffered from respiratory failure or acute respiratory distress.

• Cardiovascular toxicity. One case of hypotension was judged to be potentially related to remdesivir in a RCT of experimental therapies against Ebola. In Grein et al.’s study [see Drug Trial 3 above], hypotension (8 %), atrial fibrillation (6 %) and hypernatremia (6 %) were observed in COVID-19 patients treated with remdesivir. What is more, one case of cardiac arrest was reported in remdesivir group in a RCT in China.

• Nephrotoxicity. Grein et al [see Drug Trial 3 above] reported renal impairments [8%], acute kidney injury [6%] and hematuria [4%] of the remdesivir recipients. A COVID-19 patient in Wuhan in March 2020, suffered from acute renal failure after using remdesivir. Therefore, it is important to monitor kidney function during remdesivir treatment, particularly for those with pre-existing renal impairments or those receiving combination therapies with other nephrotoxins.

• Other adverse effects: Ebola-infected patient treated with remdesivir showed:

  - Transient rise in serum amylase.

  Grein et al.’s study (Drug Trial 3) report:
  - rash
  - multiple-organ-dysfunction syndrome;
  - deep-vein thrombosis;
  - delirium;
  - septic shock;
  - pyrexia.

  In the RCT in China, adverse events:
  - hematologic;
  - circulatory;
  - endocrine.