Comparing the effectiveness of Lopinavir/Ritonavir/Hydroxychloroquine and Atazanavir/Ritonavir/Dolutegravir/Hydroxychloroquine treatment regiments in moderate to severe COVID-19 patients
Comparison of the effectiveness of Atazanavir/Ritonavir/Dolutegravir/Hydroxychloroquine and Lopinavir/Ritonavir/Hydroxychloroquine treatment regimens in moderate to severe COVID-19 patients based on laboratory and clinical parameters
Design
Non-randomized, parallel, phase 3 trial on 60 patients with no control group
Settings and conduct
This study is being conducted in order to find a more efficient treatment for COVID-19. All study procedures will be conducted at Rasool-E-Akram general hospital (Tehran,Iran). In this study after a 10 day treatment period, treatment efficacy will be assessed based on clinical and laboratory results and also patients ICU admission, intubation and death rate.
Participants/Inclusion and exclusion criteria
inclusion criteria: Having at least three of the disease general symptoms including: Cough, fever of more than 38.5°C, Dyspnea, gastrointestinal symptoms, etc; Or having at least one of the disease characteristics including Oxygen saturation value of less than 93%, disease confirmation based on chest imaging results and a respiratory rate greater than 24 breaths per minute
Exclusion criteria: Negative COVID-19 specific PCR test result
Intervention groups
Patients are divided into two groups in this study:
1) a group receiving Lopinavir (400 mg)\ Ritonavir (100 mg) twice a day and Hydroxychloroquine (400 mg BD for the first day and 200 mg BD afterwards) tablets
1) a group receiving Atazanavir (300 mg)\ Ritonavir (100 mg) twice a day - Dolutegravir (500 mg) once a day and Hydroxychloroquine (400 mg BD for the first day and 200 mg BD afterwards) tablets
Treatment period for both groups is 10 days
Main outcome variables
Death; ICU admission; Intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210214050350N1
Registration date:2021-02-22, 1399/12/04
Registration timing:registered_while_recruiting
Last update:2021-02-22, 1399/12/04
Update count:0
Registration date
2021-02-22, 1399/12/04
Registrant information
Name
Saeed Kalantari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6635 2306
Email address
sara.minaeian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-14, 1399/11/26
Expected recruitment end date
2021-03-04, 1399/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Lopinavir/Ritonavir/Hydroxychloroquine and Atazanavir/Ritonavir/Dolutegravir/Hydroxychloroquine treatment regiments in moderate to severe COVID-19 patients
Public title
Comparing the effectiveness of Kaletra/Hydroxychloroquine and Atazanavir/Dolutegravir/Hydroxychloroquine treatment regiments in COVID-19 treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having three or more of the following conditions:(1) Cough (2) weakness (3) fever of ≥38.5°C (4) Intense fatigue (5) myalgia (6) sore throat (7) Dyspnea (8) Low appetite/Diarrhea/nausea (9) Decreased awareness
Or having one or more of the following disease characteristics: (1) Oxygen saturation value of less than 93% (2) disease confirmation based on chest imaging results (3) A respiratory rate greater than 24 breaths per minute
Exclusion criteria:
Negative COVID-19 specific PCR test result
Patients that are well enough to not need hospitalization
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-01-30, 1399/11/11
Ethics committee reference number
IR.IUMS.REC.1399.1149
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
Death
Timepoint
During treatment
Method of measurement
Clinical
2
Description
ICU admission
Timepoint
During treatment
Method of measurement
Clinical
3
Description
Intubation
Timepoint
During treatment
Method of measurement
Clinical
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive Atazanavir (300 mg)\ Ritonavir (100 mg) twice a day - Dolutegravir (500 mg) once a day and Hydroxychloroquine (400 mg BD for the first day and 200 mg BD afterwards) tablets for 10 days and during this time their clinical and laboratory parameters will be monitored
Category
Treatment - Drugs
2
Description
Control group: This group will receive Lopinavir (400 mg)\ Ritonavir (100 mg) twice a day and Hydroxychloroquine (400 mg BD for the first day and 200 mg BD afterwards) tablets for 10 days and during this time their clinical and laboratory parameters will be monitored