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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200415047080N2
Enrollment
30
Registered
2020-11-07
Start date
2020-04-04
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia induced with COVID-19. COVID-19 pneumonia , virus identified

Interventions

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

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasol Aliannejad

Tehran University of Medical Sciences

aliannejad@tums.ac.ir+98 21 8490 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026