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
Evaluation of the effectiveness of Thiamine-Ascorbic acid-Methylprednisolone (TAM) cocktail in the treatment of critically ill patients with Covid-induced pneumonia.
Design
Open-labeled, controlled, non-randomized, phase 2-3 clinical trial on 30 patients
Settings and conduct
Eligible patients who are admitted to the intensive care unit of Dr. Shariati Hospital not randomly will allocate to control or treatment group. During hospitalization outcomes will be assessed and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Agree to take an oropharyngeal PCR and venous blood sample according to the protocol,A non-pregnant man or woman 18 years of age or older entering the program , A positive covid 19 polymerase chain reaction test with at least one of the following: radiographic changes or with clinical signs requiring mechanical ventilation and Decreased blood oxygen equal or less than 94% in Room air, Women of childbearing age should have at least one method of contraception
Exclusion criteria:
Allergy to hydrocortisone or ascorbic acid or thiamine, Hospitalization less than 72 hour, Active kidney stones , The patient is in another pilot study at the same time.
Intervention groups
Intervention group: The patients will receive the cocktail contains 100 mg of Thiamine (Darou-Pakhsh) , 6 g Ascorbic acid (Darou-Pakhsh) and Methylprednisolone 250 mg (Pfizer) 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, except the cocktail composition.
Main outcome variables
changes in SF ratio; Time to mechanical ventilation weaning; Changes in Murray Score after 72 hours of enrollment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047080N2
Registration date:2020-11-07, 1399/08/17
Registration timing:retrospective
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Rasoul Aliannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2460
Email address
aliannejad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-04-04, 1399/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the effectiveness of TAC cocktail in critically ill patients with Covid 19 induced pneumonia
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tums central building ,Keshavarz boulevard,Tehran . Iran.
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-03-29, 1399/01/10
Ethics committee reference number
IR.TUMS.VCR.REC.1399.070
Health conditions studied
1
Description of health condition studied
Pneumonia induced with COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 pneumonia , virus identified
Primary outcomes
1
Description
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
2
Description
Time to mechanical ventilation weaning
Timepoint
Daily
Method of measurement
Counting the days of using ventilator
3
Description
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 outcomes
1
Description
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
2
Description
Change in National Early Warning Score (NEWS) from baseline to discharge
Timepoint
Baseline and daily
Method of measurement
Measurement of NEWS score
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Rasol Aliannejad
Street address
Shariati Hospital, Jalal Al-Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad ali Sahraian
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
141765376
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rasol Aliannejad
Position
Faculty
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
aliannejad@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rasoul Aliannejad
Position
Faculty
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
aliannejad@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rasol Aliannejad
Position
Faculty
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8863 3039
Email
aliannejad@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available