Trial NCT04434144
Publication Mohiuddin Chowdhury ATM, Research Square, 2020 (preprint)
Dates: 2020-05-02 to 2020-06-05
Funding: No specific funding (Not applicable)
Conflict of interest: no COI

Methods
RCT
Blinding: *
Location : Single center / Bangladesh
Follow-up duration (days): 35
Inclusion criteriaAll patients who tested positive for SARS-CoV-2 infection by RT PCR at Chakoria Upazilla Health Complex, Cox's Bazar; Bangladesh from May 2nd to June 5th, 2020 were initially included in this study, including those with and without 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 criteriaPatients 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
Ivermectin + Doxycycline (200 mcg/kg/100 mg)
Co-Intervention: Standard care
Duration : Once-off; 10 days
Control
Hydroxychloroquine + Azithromycin (200 mg/500 mg)
Duration : 10 days; 5 days
Participants
Randomized
125 participants (n1=63 / n2= 62)
Characteristics of participants
N=125
Mean age : 33.8
90 males
Severity : Mild: n=116 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
In the register
No
In the report
Negative PCR and resolution of symptoms
Documents
avalaible

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
High
General comment In addition to the pre-print, 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.