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Melatonin in COVID-19

Evaluation of the efficacy and safety of Melatonin in patients with COVID-19: a randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200506047323N5
Enrollment
60
Registered
2020-08-14
Start date
2020-08-22
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 disease. COVID-19, virus not identified

Interventions

Intervention 1: Intervention group: The standard treatment for COVID-19 based on the Ministry of Health's protocol including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >20 years Positive polymerase chain reaction (PCR) test for COVID-19 or/and lung involvement in imaging Primary clinical symptoms Hospitalized and moderate patients Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm

Exclusion criteria

Exclusion criteria: Patients with underlying diseases including hypertension, diabetes, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases Use of anticoagulant drugs like warfarin, hormonal drugs, alcohol, and any illegal drugs (during last 30 days) History of allergy to Melatonin Pregnancy and breastfeeding

Design outcomes

Primary

MeasureTime frame
Body temperature. Timepoint: Before intervention and daily during the study. Method of measurement: Thermometer.;Respiratory rate. Timepoint: Before intervention and daily during the study. Method of measurement: Respiratory Count.;Oxygen saturation. Timepoint: Before intervention and daily during the study. Method of measurement: Pulse oximeter.

Secondary

MeasureTime frame
Lymphocytopenia. Timepoint: Before intervention and 7 days after the start of the intervention. Method of measurement: Cell count.;C-reactive protein. Timepoint: Before intervention and 7 days after the start of the intervention. Method of measurement: C-RP kit.;Incidence of serious adverse events. Timepoint: Before intervention and daily during the study. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Fathalipour

Bandare-abbas University of Medical Sciences

m.fathalipour@hums.ac.ir+98 76 3371 0406

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 25, 2026