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IRCT20200324046850N5 IRCT 2020-04-04 Abadan University of Medical Sciences Effectiveness of vitamin C on the improvement process of patients with COVID-19 - Evaluation of the effectiveness of vitamin compared to routine medication treatment on the improvement process of patients with COVID-19 2020-10-17 anticipated 400 Complete https://irct.ir/trial/46751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is block randomization and block size of 4. Randomization sequence and concealment codes will de created by www.sealedenvelope.com website, Blinding description: Placebo will be produced with a color and taste similar to Vitamin C by Pharmacy school of Jundishapur University. 2 Covid-19. Intervention 1: Control group: Standard Protocol Drugs + placebo (in terms of appearance and color similar to vitamin C) every 12 hours for 5 days. Intervention 2: Intervention group: Standard Protocol Drugs + Vitamin C 500mg every 12 hours for 5 days. Yes - There is a plan to make this available What will be shared: -All data can be shared after the participants in the study are unrecognizable. When: The data access period after printing the article To whom: The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration. Conditions: Any analysis can be done with the consent of the main researcher. Where to obtain: s.mobarak@abadanums.ac.ir How to obtain: The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week. Comments:
public Sara Mobarak
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Abadan Iran (Islamic Republic of) 6313833177 +98 61 5326 7800 S.mobarak@abadanums.ac.ir Abadan University of Medical Sciences scientific Sara Mobarak
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Abadan Iran (Islamic Republic of) 6313833177 +98 61 5326 7800 S.mobarak@abadanums.ac.ir Abadan University of Medical Sciences Iran (Islamic Republic of) COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan 18 years no limit Both Pregnant or breast feeding women Patients with kidney stone Patients with diabetes Patients under 18 years of age Chronic renal failure Patient with urinary tract infection U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Control group: Standard Protocol Drugs + placebo (in terms of appearance and color similar to vitamin C) every 12 hours for 5 days Intervention group: Standard Protocol Drugs + Vitamin C 500mg every 12 hours for 5 days Recovery within 10 days of starting the drug. Recovery means: (no fever, no shortness of breath, no cough or improved, no fatigue or improved) for 24 hours. Timepoint: Daily. Method of measurement: Clinical observation and examination. The change of inflammatory markers. Timepoint: Admission and discharge day. Method of measurement: C-reactive protein, neutrophil-lymphocyte ratio. Rate of survival. Timepoint: Daily. Method of measurement: census report. Days admitted in hospital. Timepoint: Daily since hospitalization time. Method of measurement: Based on patient's file. Days intubated/under ventilator. Timepoint: Daily. Method of measurement: observation. Days admitted in ICU. Timepoint: Daily. Method of measurement: Based on patient's file. Time to clinical improvement (TTIC) of NEWS2 (National Early Warning Score 2) of 0 maintained for 24 hours. Timepoint: Day of admission, fifth and discharge. Method of measurement: NEWS2 (National Early Warning Score 2) questionnaire. Abadan University of Medical Sciences Approved 2020-03-17 Abadan faculty of medical sciences - Abadan Khouzestan Iran (Islamic Republic of)