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IRCT20200623047897N1 IRCT 2020-08-16 Iran University of Medical Sciences Efficacy of N-acetylcysteine in patients with COVID-19 NAC Evaluation of the efficacy and safety of oral N-acetylcysteine in treatment and recovery of patients with COVID-19 who are under treatment with routine protocols 2020-05-21 anticipated 60 Complete https://irct.ir/trial/49277 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants were classified by stratified blocked randomization method based on easy sampling method and based on therapeutic regimen (four regimens) and were randomly assigned to one of the groups receiving the intervention (routine treatment regimen+NAC) or the routine treatment regimen alone group. Randomization is done separately within each group. The size of the blocks is 4, with two allocations to the intervention group (A) and two allocations to the routine treatment group (B), which will create 6 different formats as BAAB, ABBA, ABAB, AABB, BABA, BBAA. 3 covid-19. Intervention 1: Intervention group: hospitalized patients with moderate-sever covid-19 with stable vital signs who receive NAC. In this study, for each specific routine therapeutic regimen (regimen 1: kaletra+ hydroxychloroquine and regimen 2: atazanavir / ritonavir + hydroxychloroquine), two arms of 15 people are defined (15 people in the control group who will receive only the routine regimen and 15 people in the intervention group who will receive 600 mg oral NAC three times a day in addition to the routine regimen). Intervention 2: Control group: hospitalized patients with moderate-sever covid-19 with stable vital signs who do not receive the NAC (N-acetyl cysteine) In this study, for each specific routine therapeutic regimen (regimen 1: kaletra+ hydroxychloroquine and regimen 2: atazanavir / ritonavir + hydroxychloroquine), two arms of 15 people are defined (15 people in the control group who will receive only the routine regimen and 15 people in the intervention group who will receive 600 mg oral NAC three times a day in addition to the routine regimen). 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 The study is not complete yet.
public Najmolsadat Atefi
Dermatology ward, Hazrate Rasoole Akram Hospital, Niayesh St, Satarkhan Av
Tehran Iran (Islamic Republic of) 14665354 00982164351 atefi.ns@iums.ac.ir Iran University of Medical Sciences scientific Najmolsadat Atefi
Dermatology ward, Hazrate Rasoole Akram Hospital, Niayesh St, Satarkhan Av
Tehran Iran (Islamic Republic of) 14665354 00982164351 atefi.ns@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) admitted patients with COVID-19 moderate to severe, stable patients no limit no limit Both unstable and intubated ICU patients pregnancy, breastfeeding infancy allergy and intolerance to NAC unstable vital signs or need for intubation U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: hospitalized patients with moderate-sever covid-19 with stable vital signs who receive NAC. In this study, for each specific routine therapeutic regimen (regimen 1: kaletra+ hydroxychloroquine and regimen 2: atazanavir / ritonavir + hydroxychloroquine), two arms of 15 people are defined (15 people in the control group who will receive only the routine regimen and 15 people in the intervention group who will receive 600 mg oral NAC three times a day in addition to the routine regimen). Control group: hospitalized patients with moderate-sever covid-19 with stable vital signs who do not receive the NAC (N-acetyl cysteine) In this study, for each specific routine therapeutic regimen (regimen 1: kaletra+ hydroxychloroquine and regimen 2: atazanavir / ritonavir + hydroxychloroquine), two arms of 15 people are defined (15 people in the control group who will receive only the routine regimen and 15 people in the intervention group who will receive 600 mg oral NAC three times a day in addition to the routine regimen). Time to improve symptoms such as cough, shortness of breath and lethargy. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: clinical evaluation. O2 saturation. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: clinical evaluation and pulse oximetery. Re-hospitalization after discharge. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: clinical evaluation. Duration of hospitalization. Timepoint: after discharge. Method of measurement: days. Evaluation of laboratory parameters as a series of factors: PCR and LDH, CBC, ESR, CRP Comparison of parameters at the beginning of hospitalization, during hospitalization and at the time of discharge. Timepoint: At the beginning of the hospitalization/ during hospitalization/ at discharge time. Method of measurement: lab data analysis. Check for changes in anti-inflammatory parameters (TNF-ALPHA and IL-6 if measuring kits are available). Timepoint: At the beginning of the hospitalization/ at discharge time. Method of measurement: lab data analysis. Investigation of radiological changes at the beginning of hospitalization and during hospitalization if possible. Timepoint: At the beginning of the hospitalization/ during hospitalization. Method of measurement: radiographic changes. ICU admission. Timepoint: during hospitalization. Method of measurement: clinical evaluation. Recovery or death. Timepoint: during hospitalization and after discharge. Method of measurement: clinical evaluation. Side effects. Timepoint: Time to start the intervention/ during hospitalization, two weeks after interventions. Method of measurement: Clinical, laboratory evaluation. Need change initial treatment or add new drug to the regimen. Timepoint: during hospitalization. Method of measurement: clinical assessment. Iran University of Medical Sciences Approved 2020-05-10 Ethics committee of Iran University of medical scinces Hazrat Rasool akram hospital, Mansoori ave, Sattarkhan street Teharn Tehran Iran (Islamic Republic of)