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IRCT20220407054446N1 IRCT 2022-05-22 Bandare-abbas University of Medical Sciences Evaluation of the efficacy and safety of Co-trimoxazole in patients with COVID-19 Evaluation of the efficacy and safety of Co-trimoxazole in patients with COVID-19: A randomized open-label clinical trial 2022-04-19 anticipated 60 Complete https://irct.ir/trial/62845 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, SPSS software version 18 is used for statistical analysis. To compare the main efficacy indices (Reduction of viral load of improvement of clinical symptoms) as primary and secondary outcome between study groups, t-test for continuous quantitative variables or Wilcoxon test (if t test is not used). ) Is used for quantitatively discrete ranking variables. Statistical description of qualitative variables will be in frequency or percentage of observation and Chi-square or Fisher's exact tests will be used to compare between groups. For all statistical tests, P <0.05 (two-way) is considered statistically significant, Randomization description: In this method, the number of people in each study group is equal to each other during treatment. According to the number of 60 participants (30 people in each group) and the approximate time of 10 weeks to complete the entry of people into the study, out of 10 blocks of 6 people (if there is a sufficient number of 5 blocks of 12) will be used. The procedure in this type of randomization is similar to the simple randomization method, only the number of people in the two treatment groups is the same during the treatment period. The only drawback of this method is that the last group in each block is specified. N/A Coronavirus disease (COVID-19). Intervention 1: Intervention group: Co-trimoxazole, along with standard treatment, will be administered at a dose of 960 mg (2 tablets of 480 mg) twice a day for 7 days. Intervention 2: Control group: Include patients who will receive only standard treatment in accordance with the Protocol of the Ministry of Health and Medical Education, including remdesivir and Interferon Beta-1a. Yes - There is a plan to make this available What will be shared: The data will be collected by the colleagues participating in the project When: two months To whom: Corresponding Author:Dr. Elham Barahimi GhaleGhazi , Dr. Sahar Defaei, Dr. Mehdi Hassani Azad, Dr. Mohammad Fath Alipour Conditions: Only for data collection and analysis Where to obtain: Dr. Sahar Defaei How to obtain: Written request and request of the project manager and main collaborators (Dr. Sahar Defaei, Dr. Elham Brahimi, Dr. Mehdi Hassani Azad) Comments:
public Dr. Sahar Defaei
Educational and Research Complex of the Great Prophet , Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Bandar Abbas Iran (Islamic Republic of) 79151 +98 76 3334 7000 Sahardefaee137397@gmail.com Bandare-abbas University of Medical Sciences scientific Dr. Elham Barahimi GhaleGhazi
Educational and Research Complex of the Great Prophet, Shahid Mohammadi Hospital, Jomhory Blvd, Old Airport, Bandar Abbas, Iran
Bandar Abbas Iran (Islamic Republic of) 79151 +98 76 3371 0373 dr.e.barahimi@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age 18 years or older Conscious and voluntary satisfaction Definitive diagnosis of COVID-19 disease by PCR test Hospitalized with early sign of moderate disease 18 years no limit Both Multiple organ failure Severe ARDS Septic shock Acute kidney injury (which GFR is <15) Drug allergy / Sensitivity to drugs with sulfuric structure / Intolerance to co-trimoxazole Women during pregnancy and lactation, taking other antiviral drugs, tocilizumab or plasma therapy U07.1 Severe acute respiratory syndrome [SARS] Treatment - Drugs Treatment - Drugs Intervention group: Co-trimoxazole, along with standard treatment, will be administered at a dose of 960 mg (2 tablets of 480 mg) twice a day for 7 days. Control group: Include patients who will receive only standard treatment in accordance with the Protocol of the Ministry of Health and Medical Education, including remdesivir and Interferon Beta-1a. Reduction of viral load at the end of the study. Timepoint: At the end of the seventh day or discharge time. Method of measurement: PCR(Polymerase Chain Reaction) test. Improvement of clinical symptoms during the intervention period (improvement of clinical symptoms as continuous improvement (more than 72 hours). Timepoint: Daily follow up and repeated measurements are performed at least twice per follow up. Method of measurement: Oral temperature ≥ 36.6 °C; respiratory frequency ≥24 times per minute; and oxygen saturation ≤98% without mechanical respiration. In addition, the need for oxygen therapy and ventilation with non-invasive positive pressure in daily follow up along with other clinical symptoms such as cough, muscle pain, headache, shortness of breath, weakness and lethargy, decreased sense of smell and taste, diarrhea, abdominal spasm, nausea and vomiting are recorded qualitatively. Length of hospital stay. Timepoint: Beginning of study and end of study (day 7 of study or discharge time). Method of measurement: CBC tests, subtraction count of white cells, ferritin, CRP, LDH, ESR, creatinine and serum nitrogen urea. Need to be admitted to the intensive care unit. Timepoint: Beginning of study and end of study (day 7 of study or discharge time). Method of measurement: CBC tests, subtraction count of white cells, ferritin, CRP, LDH, ESR, creatinine and serum nitrogen urea. Improvement of biochemical parameters of patients. Timepoint: Beginning of study and end of study (day 7 of study or discharge time). Method of measurement: CBC tests, subtraction count of white cells, ferritin, CRP, LDH, ESR, creatinine and serum nitrogen urea. Side effects of the drugs studied. Timepoint: Side effects are recorded daily in the studied groups. Method of measurement: Side effects of the studied drugs, especially those such as hypersensitivity reactions, allergies, doubts, anemia, hypotension, nausea and vomiting, diarrhea, gastrointestinal spasms, weakness and lethargy, headache, and rash), frequency of possible side effects due to intervention and frequency of withdrawal due to side effects are recorded daily in the studied groups. Bandare-abbas University of Medical Sciences Approved 2022-01-04 Ethics committee of Hormozgan University of Medical Sciences Infectious diseases and Tropical Diseases Research Center, After Burn Emergency, Rasoul Akram Educational and Therapeutic Complex, Islamic Republic Boulevard, Bandar Abbas, Iran Bandar Abbas Hormozgan Iran (Islamic Republic of)