Trial *
Publication Yethindra V, Int J Res Pharm Sci, 2020 (published paper)
Dates: 2020-03-12 to 2020-05-11
Funding: No specific funding (Not applicable)
Conflict of interest: No

Methods
RCT
Location : Single center / Kyrgyzstan
Follow-up duration (days): 21
Inclusion criteria1) age 18–60 years;
2) SARS-CoV-2 infection confirmed by rRT-PCR from naso and oropharyngeal swabs;
3) mild clinical status (mild clinical symptoms but no signs of pneumonia with CT scanning) and moderate clinical status (symptoms like pyrexia, respiratory symptoms, and pneumonia upon CT scanning);
4) body temperature > 37◦C and oxygen saturation (SaO2) > 93%; and
5) acceptance for recruitment in the study and providing written consent.
Exclusion criteria1)severe/critical illness;
2) allergies to umifenovir;
3) exhibiting severe side effects, such as nausea, vomiting, diarrhea, or other gastrointestinal symptoms;
4) receiving other drugs that may interact with umifenovir;
5) pregnant or lactating women;
6) cardiac, liver, or renal disease;
7) gestation or lactation; and
8)enrollment in different drug trials within the previous 30 days.
Interventions
Treatment
Umifenovir
200 mg orally 3 times a day for 1-5 days
Control
Standard care
Definition of Standard care: All patients underwent the standard treatment (antivirals, antibiotics, immunoglobulin, and corticosteroids)
Participants
Randomized
30 participants (n1=15 / n2= 15)
Characteristics of participants
N=30
Mean age : 36.5
18 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0
Primary outcome
In the register
NR
In the report
Time to clinical recovery (TTCR), a composite of body temperature and cough amelioration over 72 h.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

NR
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 Only the published article was used in data extraction and assessment of risk of bias. No trial registry, protocol or statistical analysis plan was available. Limited data to assess RoB (no information on blinding of the participants/carers/outcome assessors), and insufficient data on baseline characteristics of 30 participants included in the study.