Covid-19 Living Data

Trial NCT04405999
Publication Mikhaylov E

Funding: Public/nonprofit (the State)
Conflict of interest:

Methods
	RCT
	Location : Single cent / Russia Follow-up duration (days): 56
Inclusion criteria	Over 18 years ; employed within the emergency departments where patients with confirmed/suspected COVID-19 were admitted, intensive care units, and clinical departments.
Exclusion criteria	Symptoms of respiratory infection within the last 2 months or a history of COVID-19 ; a positive nasopharyngeal swab polymerase chain reaction (PCR) test to SARS-CoV-2 before the day of randomization ; a confirmed direct contact to a subject positive for SARS-CoV-2 within the last 14 days ; a positive serologic test (either IgM or IgG) ; history of gastric ulcer or other contraindications to bromhexine hydrochloride ; pregnancy ; any severe chronic disease.
Interventions
	Treatment Bromhexine hydrochloride (*)Co-Intervention: Y Duration : 14 days
	Control Standard care Definition of Standard care: All participants were obliged to wear personal protective equipment (PPE) as prescribed by WHO recommendations and local instructions. The PPE included respirators class FFP2 or FFP3, full skin covering, and protective eyeglasses. Duration : 14 days
Participants
	Randomized 50 participants (n₁=25 / n₂= 25)
	Characteristics of participants N=50 Mean age : 40.6 21 males
Primary outcome
	In the register Negative PCR of SARS-CoV-2 and the absence of clinical manifestations of COVID-19 infection in individuals taking Bromhexine hydrochloride 4 weeks after randomization.[ Time Frame: 4 weeks after randomization ]
	In the report
Documents available	Protocol NR 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 trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were no major differences in population, procedures, interventions or outcomes between the article and the trail registry, which was not prospective but was submitted shortly after start of recruitment, with no changes subsequently made. The study did not achieve the target sample size stated in the original registration.