Evaluation of the effect of melatonin in patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit: A structured summary of a study protocol for a randomized controlled trial

This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran.ParticipantsAll patients admitted to the ICU of Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria.Inclusion criteria1. Age>20 years2. Definitive diagnosis of COVID-19 based on RT-PCR or/and serological testing3. Severe pneumonia and lung involvement in imaging4. Signing informed consentExclusion criteria1. Underlying diseases, including convulsive disorders, chronic hepatic and renal diseases2. Use of mechanical ventilation3. History of known allergy to Melatonin4. Pregnancy and breastfeedingIntervention and ComparatorIntervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education ’s protocol, along with Melatonin soft gelatin capsule (Danna Pharmaceutical Company) at a dose of 5 mg twice a day for a period of seven days.Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education ’s protocol for a period of seven days.Main outcomesThe primary outcomes are the recovery rate of clinical symptoms and checking arterial blood gas (ABG), C-reactive protein (C-RP), Ferritin, Lactate dehydrogenase (LDH) within seven days of randomization.The secondary outcomes are time to improvement of clinical and paraclinical features and length of stay in the ICU, need for mechanical ventilation, and mortality rate within seven days of randomization.Rand...
Source: Trials - Category: Research Source Type: clinical trials