Covid-19 Living Data

Trial CTRI/2021/02/030892
Publication Jayanthi CR, Adv Ther (2022) (published paper)
Dates: 2021-02-08 to 2021-06-16
Funding: Private (Themis Medicare Ltd.; Gedeon Richter Polska)
Conflict of interest: Yes

Methods
	RCT Blinding: double blinding
	Location : Multicenter / India Follow-up duration (days): 14
Inclusion criteria	Inpatients and outpatients aged 18–75 years with laboratory-confirmed COVID-19 with mild/moderate severity (Ministry of Health and Family Welfare, India, guidelines), that is, oxygen saturation ≥90%, and respiratory rate ≤30 min−1 presenting with WHO listed symptoms of COVID-19 (complains of fever, headache, myalgia, cough, throat pain or shortness of breath) were enrolled with a score 3–5 on the Modified World Health Organization (WHO) Ordinal Scale for Clinical Improvement
Exclusion criteria	Had known hypersensitivity to any of the ingredients of the study drug were pregnant and lactating women had known history of gout or hyperuricemia (serum uric acid level >8 mg dl−1), urolithiasis, nephrolithiasis, or any degree of renal dysfunction had history of diagnosed primary congenital immunodeficiency, or acquired immunodeficiency like Human Immunoeficiency V any genetic or developmental anomaly like cerebral palsy coeliac disease lactose intolerant cancer in nonremission stage were undergoing treatment with xanthine oxidase inhibitors, uricosuric agents, diuretics, immunosuppressive agents or zidovudine had a severe cardiac, hepatic, gastrointestinal, renal, pulmonary or skin diseases were simultaneously participating in another clinical study had medical or psychological conditions deemed by the investigators to interfere with successful participation in the study were judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above
Interventions
	Treatment Inosine Pranobex 50 mg kg−1 body weight/day rounded to the nearest 500 mg dose (maximum 4 g day−1) administered in 3–4 divided doses for 10 days
	Control Placebo
Participants
	Randomized participants : Inosine Pranobex=206 Placebo=210
	Characteristics of participants N= 416 Mean age : NR 270 males Severity : Mild: n= 284/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Clinical Response on Day 11: Percentage of patients with 2 points improvement or becoming asymptomatic on the modified ordinal scale for clinical improvement at Day 11 for two treatment arms. (Prospective version of registry)
	In the report 1) Clinical Response (CR) on Day-6 in Non Hospitalized Patients (NHP); and 2) CR on Day-11 in Total Population (TP). CR referred to 2-point improvement or becoming asymptomatic (Grade-2 or less) on the modified WHO ordinal scale.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
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 and its supplement, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry (N=416). There is no change from the trial registration in the intervention and control treatments. The original registry primary outcome does not reflect the reported primary outcome as the report added an endpoint. Enrolment was paused from March 3, 2021 to May 17, 2021 for a pre-specified interim analysis; then based on those results, there was a Protocol Amendment to add an additional primary endpoint (CR at Day-6 in NHP). Some outcomes from the registry are not reported in the paper (mortality at day 14, duration of hospitalization, percentage of patients requiring oxygen; hospitalization among the outpatients; viral negative conversion).