Zie ook in gerelateerde artikelen

Update 13 juni 2020:

In Jama is 13 april 2020  een overzichtstudie gepubliceerd van alle farmaceutische medicijnen die onderzocht worden wereldwijd met tot nu toe bekende resultaten: 

Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19)A Review

Zie verder in gerelateerde artikelen voor meer artikelen over het corona virus (COVID-19) gerelateerd aan kanker en kankerpatiënten.

In de media werd afgelopen week geschreven dat remdesivir nu ook aan patiënten besmet met het corona virus in een vroeger stadium mag worden gegeven. Zelfs goedgekeurd door EMA. Echter uit een Chinese placebo gecontroleerde studie blijkt het verschil tussen placebo en remdesivir marginaal te zijn en werd de studie zelfs stopgezet wegens de bijwerkingen. Ook de studie met 1000 patiënten in Amerika gaf telerustellende resutlaten, waar slechts een verschil van 4 dagen werd gezien tussen hersteltijd. En in beide studies werd remdesivir ook gegeven naast andere middelen. Het verschil was verre van statistisch significant.

Zie o.a. dit artikel: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

Zie dit studieverslag in The Lancet: Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial

Summary

Background

No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.

Methods

We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir–ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.govNCT04257656.

Findings

Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87–1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.

Interpretation

In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.

Funding

Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.

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