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IRCT20210508051225N1 IRCT 2021-06-14 Gonabad University of Medical Sciences Effects of Shilajit (Momiai) on COVID-19 disease Comparison of the effects of Shilajit (Momiai) with placebo on clinical course, severity indices, admission duration and mortality rate in patients with moderate Coronavirus disease 2019 (COVID-19): A triple -blind randomized controlled trial 2022-05-22 anticipated 110 Complete https://irct.ir/trial/56223 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: none, Randomization description: Randomization will be done using the permuted block randomization approach with variable sizes of 2 and 4. The analyzer will use online randomization website to generate the randomization list. The allocation randomization will also be concealed using opaque sealed envelopes with random sequences, Blinding description: Capsules with shape and color similar to the intervention group capsules will be used for blinding. Patients, therapist physician, enumerator and statistician will be blinded regarding the content of the capsules. Type of treatment will be determined as A and B for the analyst; therefore, he will be unaware of the nature of the treatment. 3 COVID-19. Intervention 1: Intervention group: The intervention group will receive two 500mg Shilajit capsules per day for two weeks. Intervention group will also receive medical treatments based on moderate COVID-19 treatment protocols. Intervention 2: Control group: The control group will receive two placebo capsules per day for two weeks. Control group will also receive medical treatments based on moderate COVID-19 treatment protocols. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Sharing deidentified IPD depends on the approval by the Ethical Committee of the Gonabad University of Medical Sciences

public Narjes Bahri

Gonabad University of Medical Sciences, Imam Khomeini St., Gonabad, Khorasan Razavi

Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 nargesbahri@yahoo.com Gonabad University of Medical Sciences scientific Narjes Bahri

Gonabad University of Medical Sciences, Imam Khomeini St., Gonabad, Khorasan Razavi

Gonabad Iran (Islamic Republic of) 9691793718 +98 51 3222 2257 nargesbahri@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of moderate COVID-19 disease (based on the World Health Organization laboratory and clinical criteria) Receiving standard and routine medications for moderate COVID-19 based on management protocols for COVID-19 age between 18 and 75 years old signing the written informed consent form 18 years 75 years Both Pregnancy Lactation Immune deficiency conditions (receiving chemotherapy, organ or bone marrow transplantation, autoimmune diseases) History of chronic pulmonary disease Participating or being registered for other trials Severe renal failure (GFR< 30ml/min) Liver failure Heart failure (EF<40%) History underlying diseases including diabetes and hypertension U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: The intervention group will receive two 500mg Shilajit capsules per day for two weeks. Intervention group will also receive medical treatments based on moderate COVID-19 treatment protocols. Control group: The control group will receive two placebo capsules per day for two weeks. Control group will also receive medical treatments based on moderate COVID-19 treatment protocols. Severity of clinical presentations of COVID-19. Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: The criteria proposed by the World Health Organization will be used to determine COVID-19 severity and to assess the changes in disease severity during the study. Based on the criteria disease severity is defined based on a score between 0 and 8 as follows: (0) no clinical or virologic sign of infection (1) no limitation in activity (2) limitation in activity (3) hospital admission without oxygen therapy (4) hospital admission with oxygen therapy with mask or nasal cannula (5) hospital admission with non-invasive oxygen therapy or high flow oxygen (6) hospital admission with intubation or mechanical ventilation (7) hospital admission with supported ventilation including extracorporeal membrane oxygenation, vasopressors, or renal replacement therapy (8) death. Oxygen saturation:fraction of inspired oxygen ratio (SPO2:FiO2). Timepoint: At the beginning of the study (before intervention initiation) and 7, 14, and 28 days after Shilajit use. Method of measurement: Pulse oxymeter. Axillary temperature. Timepoint: At the beginning of the study (before intervention initiation) and daily afterwards. Method of measurement: mercury thermometer. Incidence of respiratory distress. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination. Ventilation need. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination. Intensive Care Unit admission. Timepoint: At the beginning of the study (before intervention initiation) and anytime during the study period. Method of measurement: Patient records data/Physician examination. Duration of Intensive Care Unit admission. Timepoint: anytime during the study period. Method of measurement: Patient records data/Physician examination. Time of death. Timepoint: anytime during the study period. Method of measurement: Patient records data/Physician examination. Respiratory rate. Timepoint: At the beginning of the study (before intervention initiation) and daily afterwards. Method of measurement: Patient records data/Physician examination. All-cause mortality. Timepoint: any time during the study period. Method of measurement: Incidence of death due to any cause during the study period. Hospital admission duration. Timepoint: during the study period. Method of measurement: Days from admission to discharge or decease. Intensive Care Unit admission duration. Timepoint: during the study period. Method of measurement: Days from admission in the Intensive care unit to discharge or decease. Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Incidence of Intensive Care Unit admission. Time to Intensive Care Unit admission. Timepoint: During the study period. Method of measurement: Days from hospital admission to Intensive Care Unit referral. Ventilation requirement. Timepoint: During the study period. Method of measurement: Incidence of ventilation requirement. Time to ventilation. Timepoint: During the study period. Method of measurement: Days from admission to initiation of mechanical ventilation. Gonabad University of Medical sciences Approved 2021-05-03 Gonabad University of Medical Sciences Gonabad University of Medical Sciences, Imam Khomeini St., Gonabad, Khorasan Razavi Gonabad Razavi Khorasan Iran (Islamic Republic of)