Covid-19 Living Data

Trial NCT04434144
Publication Chowdhury ATMM, EJMO (2021) (published paper)
Dates: 2020-05-02 to 2020-06-05
Funding: No specific funding (Not applicable)
Conflict of interest: No

Methods
	RCT
	Location : Single center / Bangladesh Follow-up duration (days): 35
Inclusion criteria	Patients (16 years to 80 years of age) tested positive for SARS-CoV-2 infection by Real-time polymerase chain reaction(RT-PCR) at Chakoria Upazilla Health Complex, Cox's Bazar, Bangladesh, from second may to the fifth June 2020, were initially included in this study, including those with and without the symptoms. Patients were all examined with a pulse oximeter and only those with normal oxygen saturation of 95% or above were included. Patients with respiratory symptoms received chest radiograph and only those with normal or near-normal chest radiograph were included.
Exclusion criteria	Patients with unstable comorbid conditions like bronchial asthma, COPD, ischemic heart disease, uncontrolled diabetes mellitus, advanced renal and hepatic disease, carcinoma, hospitalized, and Immuno-compromised patients
Interventions
	Treatment IVM+DX Ivermectin: 200 mcg/kg orally once off. Doxycycline: 100 mg orally once a day for 10 days.
	Control HCQ+AZM Hydroxychloroquine: 400 mg once a day orally on the first day, followed by 200 mg twice a day orally for 9 days. Azithromycin: 500 mg orally once a day for 5 days.
Participants
	Randomized participants : IVM+DX=63 HCQ+AZM=62
	Characteristics of participants N= 125 Mean age : NR 90 males Severity : Mild: n= 91/ Asymptomatic: n=25 Number of vaccinated participants: NR
Primary outcome
	In the register Number of participants with
	In the report Negative PCR and resolution of symptoms
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	High
General comment	In addition to the published/pre-print article, the trial registry was also used in data extraction and risk of bias assessment. The trial was registered as an observational study and retrospectively after enrollment was already completed. Outcomes not registered were reported in the article. There is no change from the trial registration in the intervention and control treatments. The study was updated on March 26th, 2021 with data from published report.