Covid-19 Living Data

Trial NCT04701710
Publication Chahla RE
Dates: 10/15/2020 to 12/30/2020
Funding: No specific funding (Internal funding; no financial sponsor)
Conflict of interest:

Methods
	RCT
	Location : Multicenter / Argentina Follow-up duration (days): 28
Inclusion criteria	Over 18 years of age; both sexes; no Covid-19 disease diagnosed by negative RT-PCR; personnel who perform patient care and administrative tasks identified like: i) Healthcare: medical personnel, nurses, kinesiologists, and ii) No Healthcare: administrative and cleaning personnel
Exclusion criteria	Under 18 years of age; pregnant or breastfeeding; symptoms related to COVID-19 disease; concurrent autoimmune or chronic disease; immune suppression; active infectious diseases; a history of previous SARS CoV-2 infection confirmed by RT-PCR, medical history, and a clinical questioning.
Interventions
	Treatment Ivermectin+Iota-Carrageenan (*) Duration : 4 weeks
	Control Standard care Definition of Standard care: Both groups used standard biosecurity care and personal protective equipment (PPE). Duration : 4 weeks
Participants
	Randomized 234 participants (n₁=117 / n₂= 117)
	Characteristics of participants N=234 Mean age : NR 100 males
Primary outcome
	In the register Number of subjects who were diagnosed with COVID-19 in EG and CG, Pearson's Chi-square and proportion test [ Time Frame: 4 week ]
	In the report
Documents available	Protocol Yes. In language other than English Statistical plan NR Data-sharing stated 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 pre-print article, the study protocol (in Spanish) and the retrospective trial registry were used in data extraction and assessment of risk of bias. There were some minor differences in primary and secondary outcomes between the prospective protocol, the retrospective registry and the pre-print article, but most may be language-related. Adverse events were not reported as specified in the methods and protocol. The protocol stated participants would be randomized 2:1 ratio (100 vs. 50), but a 1:1 ratio (117 vs. 117) was used. The study did not achieve the target sample size adjusted for potential losses, but as all recruited completed the study it achieved its minimum sample size.