Trial TCTR20200514001
Publication Sirijatuphat R, Emerg Microbes Infect (2022) (published paper)
Dates: 2020-12-01 to 2021-07-30
Funding: Mixed (National Research Council of Thailand; Siriraj Research and Development Fund, Faculty of Medicine Siriraj Hospital, Mahidol University; Unitaid; Wellcome Trust; EPSRC; NIH. The study drug (Favipiravir) was supported by FUJIFILM Toyama Chemical Co., Ltd.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Thailand
Follow-up duration (days): 27
Inclusion criteria
  • PCR-confirmed SARSCoV-2 infected individuals
  • 18 years or older
  • Mild-to-moderate symptoms
  • Without pneumonia
Exclusion criteria
  • Subjects with pneumonia
  • In critical condition
  • Symptomatic onset >10 days
  • Suspected or confirmed to have concurrent or concomitant infections
  • Received immunosuppressive treatment
  • Received or were on medication with possible SARS-CoV-2 antiviral activity (e.g. interferon alpha, lopinavir, chloroquine, hydroxychloroquine, ivermectin, favipiravir, and remdesivir)
  • Pregnant or possibly pregnant
  • Lactating
Interventions
Treatment
Favipiravir
Initial dose: 1800 mg orally twice a day on Day 1 - Maintenance dose: 800 mg orally twice a day until clinical improvement or saliva RT-PCR became negative (5 to 14 days).

Control
Standard care

Participants
Randomized
participants :
Favipiravir=64
Standard care=32
Characteristics of participants
N= 96
Mean age : NR
33 males
Severity : Mild: n=93 / Moderate: n=0 / Severe: n=0 Critical: n=0
Number of vaccinated participants: 0
Primary outcome
In the register
Time to improvement in body temperature and SpO2 without chest imaging findings, and negative SARS-C Day 1 to Day 28 Vital Sign, SpO2, and chest imaging
In the report
Time to clinical improvement, defined by a National Early Warning Score (NEWS) of ≤1. Primary endpoints were right-censored on Day 28.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the accepted article, the prospective study registry and supplemental material were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does not reflect the reported primary outcome. The study (n=96) achieved the target sample size specified in the trial registry (n=96).