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IRCT20231008059655N1 IRCT 2023-11-06 Ahvaz University of Medical Sciences The effect of adding nebulized low molecular weight heparin to the treatment of outpatients with Covid 19 ‏Comparison of the effect of adding nebulized low molecular weight heparin to the treatment of patients with Covid 19 who are treated with Remdesivir on an outpatient basis compared to the usual treatment during five days 2023-11-11 anticipated 42 Complete https://irct.ir/trial/73059 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants are individually divided into two groups based on the 4-way random block permutation method and using SPSS version 25 software (version 25, IBM Corporation, Armonk, NY), which is allocation concealment by using sequentially numbered, opaque, sealed envelopes will be done in random order, Blinding description: This study is a double-blind study. Participants will be divided into two groups of low molecular weight heparin nebulization and placebo nebulization, which is the same color and undetectable to the patient. In such a way that the person who administers the medicine in the two groups will be different from the person who examines the results of the interventions. The interventions are performed by the emergency nurse, but the peak flowmetry results are measured by an intern who is unaware of the intervention groups. Also, the patients and the person who analyzes the results of the study will not know about the treatment groups. 3 Covid-19. Intervention 1: Intervention group:Patients with covid 19 are treated with the appropriate dose of remdesivir (Ronak Pharmaceutical Company) (The first day with a dose of 200 mg and the second, third, fourth and fifth day with doses of 100 mg) and the appropriate dose of nebulized low molecular weight heparin (Ronak Pharmaceutical Company) (0.5 mg per kg) at the same time as receiving Remdesivir for five days. Then every day after taking the drugs, the patient's peak expiratory flow rate is recorded by the peak flowmeter and the patient's vital signs are also recorded.‏ The person who administers the medicine in the two groups will be different from the person who examines the results of the interventions. The interventions are performed by the emergency nurse, but the peak flowmetry results are measured by an intern who is unaware of the intervention groups. Also, the patients and the person who analyzes the results of the study will not know about the treatment groups. Intervention 2: Control group: Patients with covid 19 are treated with the appropriate dose of Remdesivir (Ronak Pharmaceutical Company) (The first day with a dose of 200 mg and the second, third, fourth and fifth day with doses of 100 mg) and the appropriate dose of nebulized distilled water (0.5 mg per kg) at the same time as receiving Remdesivir for five days. Then every day after taking the drugs, the patient's peak expiratory flow rate is recorded by the peak flowmeter and the patient's vital signs are also recorded.‏The person who administers the medicine in the two groups will be different from the person who examines the results of the interventions. The interventions are performed by the emergency nurse, but the peak flowmetry results are measured by an intern who is unaware of the intervention groups. Also, the patients and the person who analyzes the results of the study will not know about the treatment groups. 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 There is no further information.
public Ali Vefagh nematollahi
Emergency Medicine Department, Imam Khomeini Hospital, Azadegan St, Ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3292 3985 Shiri.t@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ali Vefagh nematollahi
Emergency Medicine Department, Imam Khomeini Hospital, Azadegan St, Ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3292 3985 Shiri.t@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Positive Covid-19 test Patients who are treated on an outpatient basis no limit no limit Both Patients with poor general condition and hospitalization in the emergency room Patients with acute medical problems U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group:Patients with covid 19 are treated with the appropriate dose of remdesivir (Ronak Pharmaceutical Company) (The first day with a dose of 200 mg and the second, third, fourth and fifth day with doses of 100 mg) and the appropriate dose of nebulized low molecular weight heparin (Ronak Pharmaceutical Company) (0.5 mg per kg) at the same time as receiving Remdesivir for five days. Then every day after taking the drugs, the patient's peak expiratory flow rate is recorded by the peak flowmeter and the patient's vital signs are also recorded.‏ The person who administers the medicine in the two groups will be different from the person who examines the results of the interventions. The interventions are performed by the emergency nurse, but the peak flowmetry results are measured by an intern who is unaware of the intervention groups. Also, the patients and the person who analyzes the results of the study will not know about the treatment groups. Control group: Patients with covid 19 are treated with the appropriate dose of Remdesivir (Ronak Pharmaceutical Company) (The first day with a dose of 200 mg and the second, third, fourth and fifth day with doses of 100 mg) and the appropriate dose of nebulized distilled water (0.5 mg per kg) at the same time as receiving Remdesivir for five days. Then every day after taking the drugs, the patient's peak expiratory flow rate is recorded by the peak flowmeter and the patient's vital signs are also recorded.‏The person who administers the medicine in the two groups will be different from the person who examines the results of the interventions. The interventions are performed by the emergency nurse, but the peak flowmetry results are measured by an intern who is unaware of the intervention groups. Also, the patients and the person who analyzes the results of the study will not know about the treatment groups. Peak expiratory flow rate. Timepoint: In this study, the time periods of measuring the peak expiratory flow rate will be measured on days 1, 2, 3, 4 and 5 after receiving the drug. Method of measurement: Peak flow meter. Saturation O2. Timepoint: In this study, the time periods of measuring oxygen saturation are measured on days 1, 2, 3, 4 and 5 after receiving the drug. Method of measurement: Pulse oximeter. Respiratory rate. Timepoint: In this study, the time periods of measuring respiratory rate are measured on days 1, 2, 3, 4 and 5 after receiving the drug. Method of measurement: Number of breaths per minute. Pulse rate. Timepoint: In this study, the time periods of measuring pulse rate are measured on days 1, 2, 3, 4 and 5 after receiving the drug. Method of measurement: The number of heartbeats per minute. Ahvaz University of Medical Sciences Approved 2023-10-01 Ethics committee of Ahvaz Jondishapur University of Medical Sciences Ahvaz Jondishapur University of Medical Sciences, Esfand St, Farvardin Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)