View older revisions Content changed at 2020-08-01, 1399/05/11

Protocol summary

Study aim
Determination of the effect of sofosbovir / daclatasavir in COVID-19 patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 and multicenter on 1000 patients.
Settings and conduct
The study is a double-blind clinical trial. The sample size is 1000. The samples are selected according to the entry criteria through the census and are assigned to the intervention and control groups by a simple random method.participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age: >=18, (including one of Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea), CT involvement compatible with COVID-19, O2Sat 94% or less Exclusion criteria: Renal failure (eGFR < 30) Bradycardia (HR < 50) Taking amiodarone, Previous sofosbuvir use, Pregnancy/lactation, Multi-organ failure on admission (2 organs or more, excluding lung), Requiring intubation on admission, Significant arrhythmia in EKG, Allergy to sofosbuvir or daclatasvir, Not consenting to the study
Intervention groups
Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days. Control group: Country Standard Pharmaceutical Protocol + placebo one tablet daily for 10 days.
Main outcome variables
Recovery within 10 days from start of medication. Recovery defined as: (O2sat ≥95% or ≥5% improvement from baseline, No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance ) for 24 hours

General information

Reason for update
Update study inclusion criteria
Acronym
DISCOVER
IRCT registration information
IRCT registration number: IRCT20200624047908N1
Registration date: 2020-07-05, 1399/04/15
Registration timing: prospective

Last update: 2020-08-01, 1399/05/11
Update count: 3
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
gholamali eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 5363
Email address
gholamali.eslami1351@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-13, 1399/04/23
Expected recruitment end date
2020-09-08, 1399/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: A randomized double-blind clinical trial
Public title
Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: >=18 including one of Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea CT involvement compatible with COVID O2Sat 94% or less
Exclusion criteria:
Renal failure (eGFR < 30) Bradycardia (HR < 50) Taking amiodarone Previous sofosbuvir use Pregnancy/lactation Multi-organ failure on admission (2 organs or more, excluding lung) Requiring intubation on admission Significant arrhythmia in EKG Allergy to sofosbuvir or daclatasvir Not consenting to the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 1000
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a randomized, double-blind, phase 3 clinical trials and multicenter on 1000 patients. Randomization method is block randomization and block size was 4. Sealed envelopes were used for allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance, So patients do not understand which group they are in. Sealed envelopes were used for allocation concealment.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Abadan School of Medical Sciences
Street address
Abadan School of Medical Sciences
City
Abadan
Province
Khouzestan
Postal code
6313833177
Approval date
2020-06-21, 1399/04/01
Ethics committee reference number
IR.ABADANUMS.REC.1399.071

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
COVID-19
ICD-10 code description
U07.1

Primary outcomes

1

Description
Recovery within 10 days from start of medication. Recovery defined as:(O2sat ≥95% or ≥5% improvement from baseline, No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance ) for 24 hours
Timepoint
Daily
Method of measurement
Clinical observation and examination

Secondary outcomes

1

Description
Recovery within 14 days from start of medication
Timepoint
Daily
Method of measurement
Clinical observation and examination

2

Description
Rate of survival
Timepoint
Daily
Method of measurement
census report

3

Description
Days admitted in hospital
Timepoint
Daily since hospitalization time
Method of measurement
Based on patient's file

4

Description
Days intubated/under ventilator
Timepoint
Daily
Method of measurement
observation

5

Description
Days admitted in ICU
Timepoint
Daily
Method of measurement
Based on patient's file

Intervention groups

1

Description
Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days
Category
Treatment - Drugs

2

Description
Control group: Country Standard Pharmaceutical Protocol + placebo one tablet daily for 10 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Abadan, Mazandaran, Gilan, Tehran, Qom, Birjand, Fasa, Shiraz and Zabol
Full name of responsible person
Gholamali Eslami
Street address
Ayatollah Taleghani Hospital , Station 12, in front of Azad University , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
-
Phone
+98 61 5336 1003
Email
gholamali.eslami1351@gmail.com

2

Recruitment center
Name of recruitment center
Abadan Oil Industry Imam Khomeini Hospital
Full name of responsible person
Gholamali Eslami
Street address
NO.671, Imam Khomeini Hospital, cyclin next to the refinery of Montazeri St, Abadan city, Khuzestan, IRAN
City
Abadan
Province
Khouzestan
Postal code
-
Phone
+98 61 5322 6811
Email
gholamali.eslami1351@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Gholamali Eslami
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 5362
Email
gholamali.eslami1351@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Gholamali Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 5362
Email
gholamali.eslami1351@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Gholamali Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
006153265362
Email
gholamali.eslami1351@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Golamali Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
006153265362
Email
golamali.eslami@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
-All data can be shared after the participants in the study are unrecognizable.
When the data will become available and for how long
The data access period after printing the article
To whom data/document is available
The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher.
From where data/document is obtainable
gholamali.eslami1351@gmail.com
What processes are involved for a request to access data/document
The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.
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