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IRCT20200415047080N2 IRCT 2020-11-07 Tehran University of Medical Sciences Evaluation of the effectiveness of TAC cocktail in critically ill patients with Covid 19 induced pneumonia Evaluation of the effectiveness of thiamine-ascorbic acid-methylprednisolone (TAM) cocktail in the treatment of critically ill patients with coronavirus pneumonia (Covid-19) in a clinical trial study 2020-04-04 anticipated 30 Complete https://irct.ir/trial/47186 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Pneumonia induced with COVID-19. Intervention 1: Intervention group: The patients will receive the cocktail contains 100 mg of Thiamine (Ampoule B complex, Darou Pakhsh Co.), 6 g Ascorbic acid (ampoule of vitamin C, Darou Pakhsh Co.) and Methylprednisolone 250 mg (Solu-Medrol, Pfizer Co.) on the first day and then 100 mg of Thiamine and 6 gr of Ascorbic acid and 125 mg of Methylprednisolone on the second and third day of treatment. The cocktail will be prepared in 200 cc dextrose 5 % and slowly infused over 10 hours. Intervention 2: Control group: Patients of this group will receive all of common treatments (including medications and procedures), except the cocktail composition. During hospitalization outcomes will be assessed and medications and procedures will be recorded. 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 Data set will be shared anonymously after publishing article by submitting a request.
public Rasol Aliannejad
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 aliannejad@tums.ac.ir Tehran University of Medical Sciences scientific Rasoul Aliannejad
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 aliannejad@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Informed written consent is obtained before the start of the study process. patient understands and agrees with planned study methods. Agree on sampling the oropharyngeal polymerase chain reaction and venous blood samples according to the protocol. A non-pregnant woman and man is 18 years of age or older when entering the program. Positive Covid 19 polymerase chain reaction test with at least one of the following: radio-graphic changes or with clinical signs requiring mechanical ventilation and air oxygen saturation level less than or equal to 94% in room air. Women of childbearing age should have at least one contraceptive method during the study 18 years no limit Both Allergic reaction to Hydrocortisone, Ascorbic acid or thiamine Hospitalization less than 72 hours Active kidney stone The patient participates in another clinical trial at the same time U07.1 COVID-19 pneumonia , virus identified Treatment - Drugs N/A Intervention group: The patients will receive the cocktail contains 100 mg of Thiamine (Ampoule B complex, Darou Pakhsh Co.), 6 g Ascorbic acid (ampoule of vitamin C, Darou Pakhsh Co.) and Methylprednisolone 250 mg (Solu-Medrol, Pfizer Co.) on the first day and then 100 mg of Thiamine and 6 gr of Ascorbic acid and 125 mg of Methylprednisolone on the second and third day of treatment. The cocktail will be prepared in 200 cc dextrose 5 % and slowly infused over 10 hours. Control group: Patients of this group will receive all of common treatments (including medications and procedures), except the cocktail composition. During hospitalization outcomes will be assessed and medications and procedures will be recorded. Duration of improvement in the ratio of incoming oxygen flow to arterial oxygen pressure (SF ratio) compared to baseline. Timepoint: at baseline and daily. Method of measurement: Measurement of SPO2/FIO2 with pulse oximetery. Time to mechanical ventilation weaning. Timepoint: Daily. Method of measurement: Counting the days of using ventilator. Change in the Murray Lung Injury Score from baseline to 72 h. Timepoint: Baseline and daily to 72 h. Method of measurement: Murray Lung Injury Score. Change in the Sequential Organ Failure Assessment (SOFA) score from baseline to 72 h. Timepoint: Baseline and daily to 72 h. Method of measurement: Measurement of SOFA score. Change in National Early Warning Score (NEWS) from baseline to discharge. Timepoint: Baseline and daily. Method of measurement: Measurement of NEWS score. Tehran University of Medical Sciences Approved 2020-03-29 Ethics committee of Tehran University of Medical Sciences Tums central building ,Keshavarz boulevard,Tehran . Iran. Tehran Tehran Iran (Islamic Republic of)