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Roozbeh et al. — Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

Journal of Antimicrobial Chemotherapy, 2020 · 10.1093/jac/dkaa501

INCONCLUSIVE · 6 flags

In plain language

This is a small Iranian double-blind randomized trial (55 outpatients) testing whether adding the hepatitis-C drug combination sofosbuvir/daclatasvir to hydroxychloroquine helps people with mild COVID-19. Its own pre-registered main question — did symptoms ease by Day 7 — came back NO: no significant difference. Fewer people in the drug arm were hospitalized (1 vs 4), but that too was not statistically significant. What the paper's conclusion leads with instead are two large, favourable results at ONE MONTH (much less fatigue and breathlessness in the drug arm) — but those one-month outcomes were NOT among the outcomes the trial registered in advance. So the honest summary is: the trial's planned test was negative, and its upbeat headline rides on after-the-fact outcomes in a study far too small to settle anything. Nothing here is fabricated, and the trial was prospectively registered and reports its null primary plainly — but the positive spin outruns the evidence, and the research program carries real conflicts of interest (one author owns stock in the company that makes the exact drug tested; the London co-authors are funded advocates for this drug as a cheap generic and declared no conflict here).

Flags — what does not hold up

• high outcome-switching — The pre-registered PRIMARY endpoint was NULL; the conclusion is built on UN-REGISTERED outcomes
  integrity moderate · impact high
• high effect-not-robust — The headline Day-30 fatigue effect is implausibly large and fragile
  integrity moderate · impact high
• moderate overstatement — Registered biomarker primaries appear unreported
  integrity moderate · impact moderate
• low coi-undisclosed — An author holds EQUITY in the manufacturer of the exact drug tested (disclosed)
  integrity notable · impact low
• low coi-undisclosed — Unitaid-funded advocacy co-authors declared "none"
  integrity moderate · impact low
• low outcome-switching — Blinding vs the registered control arm
  integrity minor · impact low

Next leads — where to look next

• 10.1093/jac/dkaa418 same-author
  this Hill IPD meta-analysis POOLS the SOF/DCV COVID trials into a POSITIVE conclusion under the same Unitaid-funded advocacy authorship that declared "none" here, and carries a published Erratum (JAC 76(6):1653) to diff — it is the apex claim this null trial feeds.
• 10.1093/jac/dkaa334 same-funder
  Sadeghi hospitalized SOF/DCV RCT; drug supplied by Fanavaran Rojan Mohaghegh Daru Co (the firm this trial's author holds equity in) and its NON-significant primary (recovery 88% vs 67%, p=0.076) is framed as benefit — same selective-emphasis mechanism, same manufacturer network.
• 10.1093/jac/dkaa332 same-institution
  Abbaspour Kasgari SOF/DCV+ribavirin moderate-COVID RCT from the same Mazandaran University network, n=48, null on its stated endpoints (stay p=0.398; ICU 0 vs 4 p=0.109) yet feeds the positive SOF/DCV narrative — same small-underpowered-RCT-into-a-pool pattern.
• https://academic.oup.com/jac/article/77/3/758/6445131 methodological-sibling
  DISCOVER (Mobarak et al.) hospitalized SOF/DCV double-blind RCT in the same pooled evidence base; check its registered-vs-reported outcome hierarchy and funder disclosure the same way (resolve the DOI before citing).

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