Comparison of the therapeutic effect of Remedsivir with a combination of interferon-beta 1A + Remedsivir on the clinical outcomes of patients with Covid-19
Design
A clinical trial with parallel, randomized, phase 3 groups per 100 patients. Excel software rand function was used for randomization.
Settings and conduct
Patients over 40 years of age with moderate to severe severity of covid19 patients admitted to Shafa Hospital in Khorramabad in the year 1400 eligible for inclusion in the study are randomly divided into two groups of intervention and control and their clinical consequences will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized patients suspected of Covid19 infection who tested positive for PCR or despite the negative PCR test who have strong clinical evidence plus typical radiographic sign of Covid19 that is difficult to justify their symptoms based on other diseases. Exclusion criteria: Dissatisfaction with participating in the study, History of severe renal failure, History of allergies to interferon or remdesivir, History of severe liver failure, Pregnancy, Lactation
Intervention groups
First intervention group: Receiving Remdesivir (with a loading dose of 200 mg on the first day and then a daily dose of 100 mg. Second Intervention group: Receiving Interferon-beta 1A with a dose of 12 million units + Remdesivir with a loading dose of 200 mg on the first day and then a dose of 100 mg daily
Main outcome variables
Duration of hospitalization, the Survival rate of 28 days from the time of hospitalization, The duration of recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200721048159N4
Registration date:2021-09-03, 1400/06/12
Registration timing:registered_while_recruiting
Last update:2021-09-03, 1400/06/12
Update count:0
Registration date
2021-09-03, 1400/06/12
Registrant information
Name
Forouzan Ahmadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0239
Email address
ahmadpoor.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Remdesivir with Remdesivir and Interferon Beta-1 a Treatment Regime on Clinical Outcome of Covid 19 Patients
Public title
Efficacy of Remdesivir in Comparison with Interferon Beta-1 a and Remdesivir in the Treatment of Covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients suspected to Covid19 infection
SpO2 less than 93%
The presence of respiratory symptoms (including shortness of breath, pain and pressure in the chest)
older than 40 years
Exclusion criteria:
Dissatisfaction with participating in the study
History of severe renal failure
History of allergies to interferon or remdesivir
History of severe liver failure
Pregnancy
Lactation
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were randomly divided into two groups (Group A, receiving remedsivir alone and B, receiving remedsivir plus interferon beta 1-a) using a simple random method (using a random number table of the Excel function rand software). In Excel software, patients' names are entered in a column and then the RAND function is used to assign a random number to each cell.Then several cells are selected using the Index Rank formula.
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 Lorestan University of Medical Sciences
Street address
Lorestan, Khorramabad, 3 km of Khorramabad Road, Tehran, Pardis University Complex, Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Office of Research Ethics Committee
City
Khorramabad
Province
Lorestan
Postal code
381351698
Approval date
2021-07-10, 1400/04/19
Ethics committee reference number
IR.LUMS.REC.1400.090
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
Duration of hospitalization
Timepoint
7 -14 days
Method of measurement
Based on patient file information
Secondary outcomes
1
Description
The duration of recovery or the duration of entry into the disease stage
Timepoint
7-14 days
Method of measurement
Based on patient file information
2
Description
Survival rate of 28 days from the time of hospitalization
Timepoint
28 days after starting the study
Method of measurement
Interview with the patient or her family
3
Description
the amount of arterial oxygen saturation
Timepoint
Daily
Method of measurement
Using a device to measure the percentage of oxygen saturation
4
Description
Frequency of transfer to intensive care unit
Timepoint
Daily
Method of measurement
Under supervision
Intervention groups
1
Description
First intervention group: Receiving Remdesivir (Ronak Daru Pharmaceutical Company) with a loading dose of 200 mg on the first day and then a daily dose of 100 mg by intravenous injection for 7-14 days depending on the patient's clinical condition in addition to standard treatment according to national guidelines, (Which includes corticosteroids (dexamethasone or methylprednisolone) and anticoagulants (heparin or enoxaparin).)
Category
Treatment - Drugs
2
Description
Second Intervention group: Receiving Interferon-beta 1A (Sinagen Pharmaceutical Company) with a dose of 12 million units of subcutaneous injection every other day + Remdesivir (Ronak Pharmaceutical Company) with a loading dose of 200 mg on the first day and then a dose of 100 mg daily Intravenously for 7-14 days based on the patient's clinical condition in addition to standard treatment according to national guidelines, (Which includes corticosteroids (dexamethasone or methylprednisolone) and anticoagulants (heparin or enoxaparin).)