Evaluation of the therapeutic effect of Molnupiravir in COVID-19 patients with moderate-severity referred to the infectious disease clinic of Labbafinejad hospital in 2022
Design
Randomized, double-blinded clinical trial, with two intervention and control groups (allocation ratio 1:1).
Settings and conduct
This study was performed on patients with moderate COVID-19 referred to the infectious diseases clinic of Labbafinejad hospital in 2022. Eligible patients, they are divided into two groups of intervention and control using a random number table. The intervention group, in addition to supportive and symptomatic treatment, receives oral Molnupiravir (according to the order mentioned above). The control group recieves standard medication and placebo. A trained clinical evaluator then reports patients' recovery on days 1 (start of treatment), 3, 5, and 7. Blood tests are also taken from the patient on days 1 and 7. In this double-blinded study, the patients and the physician who assessing the clinical outcomes are blind to the patients allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Laboratory confirmation of Coronavirus disease-19 (COVID-19) virus by reverse transcription- polymerase chain reaction (RT-PCR); Moderate-severity disease; Age over 18 years; Patient willingness to participate in the study; Non-pregnant and non-lactating women; No history of anaphylactic shock. Exclusion criteria are: Not completing 5-days medication, all visits and laboratory tests; Development of anaphylactic shock during the study; Occurrence of oral intolerance during clinical course.
Intervention groups
The intervention group, in addition to supportive treatment, receives oral Molnupiravir at a dose of 800 mg every 12 hours for 5 days. The control group also receives standard medication and placebo.
Main outcome variables
Hospitalization during follow-up period.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210901052358N1
Registration date:2022-01-03, 1400/10/13
Registration timing:prospective
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Amirreza Keyvanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4483 1899
Email address
amirrezakeyvanfar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Molnupiravir on Clinical and Laboratory Findings of Patients with moderate COVID-19
Public title
The Therapeutic Effect of Molnupiravir in COVID-19 Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory confirmation of Coronavirus disease-19 (COVID-19) virus by reverse transcription- polymerase chain reaction (RT-PCR)
Moderate-severity disease (respiration rate more than 30 per minute, oxygen saturation more than 94%, or pulmonary infiltration less than 50% in both lungs)
Age over 18 years
Body mass index less than 40 kilogram per square meters
No immunosuppressive diseases, including primary and secondary immunodeficiency, consumption of immunosuppressive drugs, organ transplants, chemotherapy or radiotherapy
Patient willingness to participate in the study
Existence of oral tolerance
Non-pregnant and non-lactating women
Not receiving antiviral drugs and other effective drugs in the treatment of COVID-19 in this clinical course
No history of severe drug allergy and anaphylactic shock
Exclusion criteria:
Not completing the 5-day treatment period, not completing all visits or laboratory tests
Development of severe drug hypersensitivity and anaphylactic shock during the study
Occurrence of oral intolerance in the clinical course
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and physicians who play the role of prescribing medication and evaluating clinical symptoms will be unaware of the classification of patients into intervention and placebo groups (double-blind). Others, including methodologist, statistics specialist, nurses, authors of manuscript, and study designers, will be aware of the classification of patients into the two groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of medicine of Shahid Beheshti University of medical sciences, Koodakyar Ave., Daneshjoo Blvd,. Yaman St,. Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.675
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Hospitalization during the follow-up period
Timepoint
Seventh day from the beginning of treatment
Method of measurement
Patient medical record
2
Description
Body temperature
Timepoint
Days 1 (start of treatment), 3, 5 and 7
Method of measurement
Thermometer
3
Description
Respiratory rate
Timepoint
Days 1 (start of treatment), 3, 5 and 7
Method of measurement
Physical examination by physician
4
Description
Oxygen saturation
Timepoint
Days 1 (start of treatment), 3, 5 and 7
Method of measurement
Pulseoxymeter
Secondary outcomes
1
Description
Serum CRP level
Timepoint
Days 1 (start of treatment) and 7
Method of measurement
Laboratory report
2
Description
Lymphocyte count
Timepoint
Days 1 (start of treatment) and 7
Method of measurement
Laboratory report
3
Description
Platelet count
Timepoint
Days 1 (start of treatment) and 7
Method of measurement
Laboratory report
4
Description
Neutrophil: Lymphocyte ratio
Timepoint
Days 1 (start of treatment) and 7
Method of measurement
Laboratory report
Intervention groups
1
Description
Intervention group: Patients in the intervention group, in addition to standard medication (serum therapy, analgesics, antipyretic, and vitamine), take oral Molnupiravir at a dose of 800 mg every 12 hours for 5 days. Molnupiravir is prepared by Mana Teb Daya Company.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group, in addition to standard medication (serum therapy, analgesics, antipyretic, and vitamine), take oral placebo every 12 hours for 5 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad hospital
Full name of responsible person
Amirreza Keyvanfar
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
amirrezakeyvanfar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, No. 2, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?