1. Home
  2. Approved trials
  3. » فارسی

A single-arm multicenter clinical trial to evaluate the safety and efficacy of Remdesivir in COVID-19 patients with progressive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Protocol summary

Study aim
The aim of the study is to evaluate the safety and efficacy of Remdesivir in the treatment of COVID-19
Design
This study is a single-arm, uncontrolled, open-label clinical trial to evaluate the safety and efficacy of Remdesivir in COVID-19 patients.
Settings and conduct
This multicenter, single-arm, open-label clinical trial will be carried out from March 20, 2020, in different medical universities of Iran. Each recruitment center consecutively enrolls between 5 and 10 eligible patients who meet the eligibility criteria and sign the informed consent by themselves or their guardians (in case of decreased level of consciousness or cognitive impairment). Eligible patients are followed for 14 days (from the beginning of the intervention). Each hospital will report its findings to the DSMB after the enrolling of the three patients. They may enroll subsequent patients, after obtaining authorization from DSMB. Primary outcomes and serious adverse events (SAEs) will be received daily. Secondary outcomes and paraclinical and radiologic details of patients will be obtained through hospital records (due to the workload of centers).
Participants/Inclusion and exclusion criteria
Inclusion criteria: All confirmed COVID-19 patients who are still progressing despite receiving standard treatment. Exclusion criteria: Different treatment with national protocol, under mechanical ventilation and evidence of multiple organ failure.
Intervention groups
Patients in the intervention group receive remdesivir (200 mg on the first day followed by 100 mg per day) in addition to the standard treatment
Main outcome variables
TTCI: time (day) to clinical improvement (2 score improvement of six categorical scores ranging from death to complete recovery) and TTCR: time (hr) to the normalization of fever, respiration, cough, and blood oxygen level is considered as the primary outcomes of this study.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171122037571N2
Registration date: 2020-04-12, 1399/01/24
Registration timing: registered_while_recruiting

Last update: 2020-04-12, 1399/01/24
Update count: 0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Hamed Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
hmdhosseini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A single-arm multicenter clinical trial to evaluate the safety and efficacy of Remdesivir in COVID-19 patients with progressive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Public title
Remdesivir in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ablility to fully understand, willingness to participate, and signing the informed consent form (in case of decreased level of consciousness or/ and cognitive impairment, informed consent is obtained from their legal representative) Ages over 18 years Patients with a definitive diagnosis of SARS-CoV-2 virus based on PCR with specific pulmonary involvement in radiography who have progressive hospital course (SpO2 <85% or RR > 30) despite receiving standard of care treatment protocols within 72 hours
Exclusion criteria:
Participants in any other clinical trial for COVID-19 Concomitant treatment with other antiviral drugs other than those recommended in the national protocol Patients undergoing mechanical ventilation at the time of baseline Evidence of multiorgan failure in the patient's clinical record based on the physician's diagnosis Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times the upper limit of normal (ULN) Creatinine clearance less than 50 ml/min The presence of any concurrent major diseases including malignancy, advanced heart failure, cirrhosis, chronic kidney disease, stroke, Alzheimer's, chronic progressive neurological diseases, etc. Pregnant and lactating women Possibility of being transferred to another hospital with no access to the study drug (for any reason)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Medicine used in study was provided by International donation as Compassionate use under the supervision of the Ministry of Health and Medical Education. The study was approved by the TUMS ethics committee and received a Clinical Trial Authorization- CTA from the Food and Drug Administration before the study began.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1076

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Clinically-epidemiologically diagnosed COVID-19, Probable COVID-19, Suspected COVID-19

Primary outcomes

1

Description
Time to Clinical Improvement (TTCI): TTCI is defined as the time (in days) from initiation of study treatment until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death).6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy;3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation;HFNC, High-flow nasal cannula.
Timepoint
Daily for 14 days
Method of measurement
Based on clinical evaluation

2

Description
Time to Clinical recovery (TTCR): TTCR is defined as the time (in hours) from initiation of study treatment until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough sustained for at least 72 hours.Normalization and alleviation criteria:• Fever - ≤36.9°C or -axilla, ≤37.2 °C oral,• Respiratory rate - ≤24/minute on room air,• Oxygen saturation - >94% on room air,• Cough - mild or absent on a patient-reported scale of severe, moderate, mild, absent.
Timepoint
Daily for 14 days
Method of measurement
Based on clinical evaluation

Secondary outcomes

1

Description
Percentage of patients with improved oxygen supply: Percentage of patients with improved oxygen supply (at least one step in reducing oxygen supply) including 1-no need for additional oxygen supply. 2. Nasal oxygen catheter inhalation 3. Oxygen inhalation with mask. 4- NIV 5- Ventilator
Timepoint
Daily for 14 days
Method of measurement
Based on clinical evaluation

2

Description
PaO2 / FiO2 ratio: lowest fraction recorded in a day
Timepoint
Daily for 14 days
Method of measurement
Oximeter

3

Description
The extent of lung involvement in CT scan
Timepoint
At baseline and 14th day
Method of measurement
Radiologist report basis

4

Description
Any adverse event
Timepoint
During the study period
Method of measurement
Any events during the study according to the patient's report or physician's judjment

5

Description
All cause mortality
Timepoint
During the 28 days after starting the intervention
Method of measurement
Hospital death record or statement by relatives after discharge

Intervention groups

1

Description
Intervention group: In addition to standard treatment:(two-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate; single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days or alternatively, atazanavir OR three-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate; single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days and ribavirin 1200 mg BID for at least 5 days)Remdesivir is also prescribed for 5 days (for patients over 40 kg or more: Amp Remdesivir 200 mg IV infusion over 30 minutes once-daily dose, followed by 100 mg iv infusion over 30 minutes once-daily maintenance doses for next 4 days.For patients weighing less than 40 kg: Amp Remdesivir 5 mg/kg IV infusion over 30 minutes loading dose on day 1, followed by 2.5 mg/kg iv infusion over 30 minutes once-daily maintenance doses for next 4 days)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Reza Salehi
Street address
Imam Khomeini Hospital, Keshavarz Blvd at Gharib St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8896 3546
Email
ctc@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir/

2

Recruitment center
Name of recruitment center
Masih Daneshvari
Full name of responsible person
Payam Tabarsi
Street address
Daar Abad, Niavaran, Masih Daneshvarai Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 6000
Fax
+98 21 2610 9680
Email
pr.nritld@sbmu.ac.ir
Web page address
https://nritld.sbmu.ac.ir/index.jsp?fkeyid=&siteid=200&pageid=1419

3

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Azar Haddadi
Street address
Sina Hospital, Hasan Abad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
Hadadiaz@tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir/

4

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mostafa Ghanei
Street address
Baqiyatallah Hospital, Mulla Sadra Street, Vanak Square, Tehran, Iran.,
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Fax
+98 21 8805 0436
Email
m.ghanei@bmsu.ac.ir
Web page address
https://baq.bmsu.ac.ir/Portal/home/?283090/english

5

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Saeed Kalantari
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2564
Fax
+98 21 6650 2248
Email
kalantari.s@iums.ac.ir
Web page address
https://hrmc.iums.ac.ir/

6

Recruitment center
Name of recruitment center
Loghman Hospital
Full name of responsible person
Ilad Alavi Darazam
Street address
Makhsoos St, South Karegar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Fax
+98 21 5541 7547
Email
Ilad13@yahoo.com
Web page address
http://lhmc.sbmu.ac.ir/

7

Recruitment center
Name of recruitment center
AmirAlam Hospital
Full name of responsible person
Mehrdad Hasibi
Street address
Saadi St., Enghelab St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6672 7060
Fax
+98 21 6670 4805
Email
mehrdad_hasibi@yahoo.com
Web page address
http://amiralam.tums.ac.ir/

8

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Farzin Khorvash
Street address
Al-Zahra Hospital, Soffeh Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
Farzin300@gmail.com
Web page address
http://alzahra.mui.ac.ir/

9

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Rozita Khodashahi
Street address
Imam Reza Hospital, Imam Reza square, Ibne Sina Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3845
Fax
+98 51 3858 3845
Email
khodashahir@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir/

10

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Aydin PoorKazemi
Street address
Razi Hospital, Sardar St., Rasht, Iran.
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3355 0028
Fax
+98 13 3355 9787
Email
razi.hospital@yahoo.com
Web page address
http://www.gums.ac.ir/razi/default.aspx?tabid=444

11

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Farhang BabaMahmoudi
Street address
Razi Hospital, Yusef Reza St., GhaemShahr, Iran.
City
Ghaemshahr
Province
Mazandaran
Postal code
4765686743
Phone
+98 11 4221 8018
Fax
+98 11 4221 8011
Email
Farhang.baba@yahoo.com
Web page address
https://razihospital.mazums.ac.ir/

12

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Mansooreh Momen-Heravi
Street address
Ravandi Blvd, Beheshti Hospital, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
mansoreheravi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Malekzadeh
Street address
Digestive Disease Research Institute, Shariati Hospital, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Fax
+98 21 8241 5400
Email
info@ddri.ir
Web page address
https://ddri.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Hamed Hosseini
Position
Assisstant professor in Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
23rd Unit, 4th Floor, No. 1547, North Kargar St.,
City
Tehran
Province
Tehran
Postal code
1417993337
Phone
+98 21 8896 3546
Fax
+98 21 8896 3546
Email
ctc@tums.ac.ir
Web page address
http://ctc.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Salehi
Position
Assistant Professor of Infectious Disease
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeini Hospital Complex, Gharib | Keshavarz intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
0098 21 61190
Email
imamhospital@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Hosseini
Position
Associate professor in Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
23 th unit, 4th floor, No 1547, North Kargar Street,
City
Tehran
Province
Tehran
Postal code
1417993337
Phone
+98 21 8896 3546
Fax
+98 21 8896 3546
Email
hmdhosseini@gmail.com
Web page address
http://ctc.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The DSMB decides how the results will be disseminated after reviewing the preliminary data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...