Covid-19 Living Data

Trial *
Publication Kishoria N, PIJR, 2020 (published paper)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: Unblinded
	Location : Single center / India Follow-up duration (days): 6
Inclusion criteria	Patients aged 18 years and above; positive test after completion of standard care treatment for SARS-CoV-2 confirmed by reverse transcriptase–polymerase-chain-reaction (RT-PCR) assay; mild/ asymptomatic; no comorbidities rendering high-risk patients; informed consent obtained.
Exclusion criteria	Allergy or hypersensitivity to ivermectin and/or its inactive ingredients; respiratory distress or requiring intensive care; used immunosuppressants (including systemic corticosteroids) in the last 30 days; known HIV infection with CD4 count <300 cell/ L; pregnancy or lactating patients; medical conditions such as malabsorption syndromes affecting proper ivermectin absorption; autoimmune disease and/or decompensated chronic diseases; Uncontrolled, intercurrent diseases including renal impairment, hepatic impairment, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia; treated in any other study in the previous 30 days; concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity.
Interventions
	Treatment Ivermectin 12 mg single dose
	Control Standard care ( / ) Definition of Standard care: Standard care. Hydroxychloroquine 400 mg twice a day Paracetamol 500mg as required. Vitamin C 1 tab twice a day. Plenty of water with caloric diet intake. Temperature and spo2 monitoring. Good oral hygiene.
Participants
	Randomized 32 participants (n₁=19 / n₂= 13)
	Characteristics of participants N=32 Mean age : 38.5 23 males Severity : Mild: n=32 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
	In the register NR
	In the report Negative throat swab report for SARS-CoV-2 conducted by RT-PCR after 48 hours of day one of research therapy. However if patient was tested positive on the then the test was repeated again after 48 hours.
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 the risk of bias. No trial registry, study protocol or statistical analysis plan was available. The sample included in this hospital-based study was small due to change in guidelines during the study in which asymptomatic patients and patients with mild symptoms were recommended to be home isolated and not hospitalized. Safety outcomes such as adverse events or death are not reported.