Protocol summary

Study aim
Evaluation of the therapeutic effect of Remdesivir on covid-19 patients referring to Ahvaz Jundishapur University of Medical Sciences hospitals, A single-arm clinical trial study
Design
Single-arm clinical trial study, without control group, with a sample size of 50 people, , Phase 2_3 of Clinical trial
Settings and conduct
The place of the study is Ahvaz University of medical science hospitals, simple sampling of patients without randomization, without blinding, Single-arm clinical trial study, RemedSivir is used
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age ≥18 years, Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19, Severe pulmonary involvement in imaging, Oxygen saturation less than 90% with canola nasal or respiratory rate more than 30. Exclusion criteria: Treatment with other antiviral drugs not listed in the national protocol, Underlying disease, Allergic reaction to Remdesivir, Pregnant or lactating women, Possibility of transfer to another hospital, Evidence of multiple organ failure, Receive any experimental treatment for Covid 19, Patients under mechanical ventilation at the beginning of the study, Alanine Aminotransferase or Aspartate Aminotransferase more than 5 times normal, Creatinine clearance less than 50 ml per minute
Intervention groups
Main group: On the first day of treatment with RamedSivir with two 100 mg vials intravenously for 30 minutes to two hours and then 100 mg daily on the second, third, fourth and fifth days Takes. Each vial is prepared with 19 cc of distilled water and diluted with 0.9% saline.
Main outcome variables
Long of stay, oxygen saturation, fever, dyspnea, cough, Respiratory rate , lymphocyte blood count, C_ reactive protein, Alanine Amino Transferase, Aspartate Aminotransferase

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200404046937N5
Registration date: 2020-10-14, 1399/07/23
Registration timing: registered_while_recruiting

Last update: 2020-10-14, 1399/07/23
Update count: 0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Mehran Varnaseri ghandali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7446
Email address
varnaseri-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-27, 1399/07/06
Expected recruitment end date
2020-10-27, 1399/08/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of Remdesivir on COVID-19 patients, A single-arm clinical trial study
Public title
Effect of remdesivir in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19 Severe pulmonary involvement in imaging that progresses despite receiving standard treatment protocols within 72 hours of starting antiviral therapy Oxygen saturation less than 90% with canola nasal or respiratory rate more than 30
Exclusion criteria:
Treatment with other antiviral drugs not listed in the national protocol Comorbidities such as malignancy, advanced heart failure, cirrhosis, dialysis patients, stroke, Alzheimer's, advanced neurological disease, progressive respiratory disease Allergic reaction to Remdesivir Pregnant or lactating women Possibility of transfer to another hospital that does not have access to study drugs Evidence of multiple organ failure Receive any experimental treatment for Covid 19 Patients under mechanical ventilation at the beginning of the study Alanine Aminotransferase or Aspartate Aminotransferase more than 5 times normal Creatinine clearance less than 50 ml per minute
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical
Street address
Ethics committee, main building, Ahvaz University of medical science, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6133744151
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.AJUMS.REC.1399.407

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Corona virus infection, unspecified

Primary outcomes

1

Description
Length of stay
Timepoint
The first day and the last day of the patient's hospitalization
Method of measurement
patient file

2

Description
Oxygen Saturation
Timepoint
Daily
Method of measurement
Pulls oximeter

Secondary outcomes

1

Description
Fever
Timepoint
Daily
Method of measurement
Thermometer

2

Description
Dyspnea
Timepoint
Daily
Method of measurement
Patients interview and patient file

3

Description
Cough
Timepoint
Daily
Method of measurement
Patients interview and patient file

4

Description
Respiratory Rate
Timepoint
Daily
Method of measurement
Patients interview and patient file

5

Description
C-Reactive protein
Timepoint
The first day and the seventh day of study
Method of measurement
Agglutination kit

6

Description
Lymphocyte blood count
Timepoint
The first day and the seventh day of study
Method of measurement
Cell counter

7

Description
Alanine Amino Transferase
Timepoint
The first day and the seventh day of study
Method of measurement
Determination of enzyme in serum by biochemical method

8

Description
Aspartate Aminotransferase
Timepoint
The first day and the seventh day of study
Method of measurement
Determination of enzyme in serum by biochemical method

Intervention groups

1

Description
Intervention group: Patients in the main group recived Remdesivir consisting of two 100 mg vials, ie 200 mg intravenously, which is infused over a period of 30 minutes to two hours, on the first day of treatment with followed by 100 mg daily on the second, third, fourth and fifth day. Each vial is prepared with 19 cc of distilled water and diluted with 0.9% saline. Patients will be monitored daily and at the end of the 5-day treatment period
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Fatemeh Ahmadi
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
ahmadi-f@ajums.ac.ir

2

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mehran Varnasseri
Street address
Sina hospital, 5th Gandomkar st, Koot Abdollah Ave
City
Ahvaz
Province
Khouzestan
Postal code
6155819993
Phone
+98 61 3555 0592
Email
drvarnasseri.m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Main building, Ahvaz University of Medical Science, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3311 3815
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Roohangiz Nashibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
dr.r.nashibi@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnasseri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasseri.m@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnaseri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasseri.m@gmail.com

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
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