MedPath

Melatonin and Covid-19

Phase 2
Recruiting
Conditions
covid-19.
COVID-19 Disease
U07.01
Registration Number
IRCT20210505051197N1
Lead Sponsor
Rasht University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
96
Inclusion Criteria

RT-PCR test positive for SARS-CoV-2
criteria for patients with moderate symptoms:evidence of lower respiratory disease( dyspnea, Chest compression ?..)
oxygen saturation (SpO2) between 90 to 93%
lung infiltrates<50%
criteria for patients with sever symptoms: Dyspnea
respiratory frequency >30 breaths/min
oxygen saturation (SpO2) < 90% and PaO2/FiO2 <300 mm Hg
lung infiltrates >50%

Exclusion Criteria

patients with mild symptoms
diabetes
hypertension
pregnant women
those who have already been in clinical trial with other drugs.
Age less than 18 years

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
C-Reactive Protein serum levels. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: By ELISA.;Erythrocyte sedimentation rate serum levels. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: erythrocyte sedimentation rate per hour.
Secondary Outcome Measures
NameTimeMethod
Outcome of the disease. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: Reduction of clinical sign and symptoms, no need for supplemental oxygen or mechanical ventilation.;Ferritin. Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: by ELISA.;VitD(25OH). Timepoint: Morning of the first day (before the intervention), fourth day (day after the third intervention) and sixth day (day after the last intervention). Method of measurement: by ELISA.;Days of hospitalization. Timepoint: Until discharge or death. Method of measurement: Based on the days of hospitalization.
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