Trial IRCT20200511047399N1
Publication Sedighiyan M, Authorea, 2021 (preprint)
Dates: 2020-02-01 to 2020-04-30
Funding: Public/non profit (Tehran University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Single center / Iran
Follow-up duration (days): 14
Inclusion criteriaAdults aged >18 years;
Diabetes mellitus;
Body mass index >18.5;
Diagnosed with Covid-19 according to the decision of the relevant physician
Exclusion criteriaPregnant, lactating and menopause women;
Diagnosis of International Normalized Ratio (INR) or platelet abnormalities;
Known history of liver, kidney or thyroid abnormalities;
Pancreatitis;
Any malignancy;
Smoking;
Drug and alcohol abuse;
Other conditions causing inflammatory state;
Individuals who had regularly consumed omega-3 supplements during 3 months before study baseline
Interventions
Treatment
Hydroxychloroquine+Omega-3 ( / )Co-Intervention: Standard care
Duration :
Control
Hydroxychloroquine ( / )
Participants
Randomized
39 participants (n1=20 / n2= 19)
Characteristics of participants
N=39
Mean age : 66.8
18 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=*
Primary outcome
In the register
Erythrocyte sedimentation rate (ESR); C-reactive protein; Fatigue; Body pain; Appetite; Olfactory
In the report
C-reactive protein (CRP); Erythrocyte sedimentation rate (ESR); Clinical symptoms including body pain, fatigue, appetite, and olfactory
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
*
General comment This study is pending contact with authors. No outcome data relevant to the COVID-19 NMA were reported.

In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study was registered after completion of the study. The study was unblinded to patients and investigators; outcome assessors were blinded. The study reported on CRP- and ESR levels, symptoms through a self-reported questionnaire, and side effects in the intervention group (there were none) after 2 weeks of treatment.