Trial CTRI/2020/09/027535
Publication Ramachandran R, Int. J. Infect. Dis. (2021) (published paper)
Dates: 2020-10-03 to 2021-04-28
Funding: Public/non profit (Council of Scientific and Industrial Research, Ministry of Science and Technology, Government of India)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Multicenter / India
Follow-up duration (days): 28
Inclusion criteria
  • Aged 18-75 years, at the time of signing the Informed Consent Form (ICF)
  • Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens
  • Asymptomatic or mild (uncomplicated upper respiratory tract viral infection and who may have non-specific symptoms such as fever, cough, expectoration, shortness of breath, myalgia, fatigue, sore throat, nasal congestion, diarrhea, loss of taste) or moderate (Pneumonia with no signs of severe disease, including adults with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute) disease
Exclusion criteria
  • Severe covid with respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air
  • Acute respiratory distress syndrome (ARDS)
  • Sepsis/ septic shock
  • Pregnant/ lactating women
  • Severe lever disease, severe renal impairment, or other comorbidities like asthma, diabetes with second and third line medicines as defined in the WHO guidance document
Interventions
Treatment
Umifenovir
800 mg orally twice daily for 14 days
Control
Standard care

Participants
Randomized
participants :
Umifenovir=66
Standard care=66
Characteristics of participants
N= 132
Mean age : NR
92 males
Severity : Mild: n=* / Moderate: n=41 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Time from randomization to nasopharyngeal swab negativity by RT-PCR tests; For moderate patients: time to improvement by one category from randomisation on the eight-category ordinal scale defined by WHO & average change in the ordinal scale from baseline
In the report
Mild-asymptomatic patients: Time from randomization to nasopharyngeal swab negativity by two RT-PCR tests, for SARS-Cov-2 antigens, taken 24 hours apart; Moderate patients: time to improvement by one category from randomisation on the eight-category ordinal scale defined by WHO & average change in the ordinal scale from baseline
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

N
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 published article, the study registry and protocol were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcomes reflect the reported primary outcomes. Some outcomes (e.g. mortality) are reported in the paper, but was not pre-specified in the trial registry/protocol. Participants were stratified at randomization and analyzed by severity at baseline (asymptomatic + mild or moderate severity).