Evaluation and comparison of the effectiveness of Hydroxychloroquin versus Clarithromycin in recovery of dyspnea and Caugh at the end of the acute phase of COVID-19 treatment
Comparison of the effectiveness of Hydroxychloroquine versus Clarithromycin in Patients with Persistent dyspnea and cough at the end of acute phase COVID-19
Design
The study is a clinical trial that is performed with a Parallel design as a pilot in three groups and each group contains 15 patients. Classification of patients into three groups is done via a simple random method by selecting sealed envelopes containing A, B, C cards. This study is done without blinding.
Settings and conduct
Patients with inclusion criteria, are randomly placed in three groups. In the initial visit of patients , a detailed history of demographic characteristics and the disease in the acute phase will be obtained. Laboratory tests beside baseline CT-SCAN are requested and patients' dyspnea and pulmonary function will be measured .we give hydroxychloroquine , clarithromycin in
two interventionals groups and we give nothing in control group . The assessment is performed without blinding. At the end of 4 weeks, reassessment of dyspnea and cough - laboratory findings - and lung function are performed separately in each group and compared with each other.
Participants/Inclusion and exclusion criteria
The main inclusion criteria is all patients aged between 20 - 50 years with a history of coronavirus who have dyspnea and cough beside evidence of involvement in chest CT despite after two weeks of recovery.
The most important exclusion criteria is patients having underlying cardiopulmonary diseases or they are taking medications Which interact with drugs that have been selected in this study.
Intervention groups
Intervention group 1: Tablet Hydroxychloroquine 200 mg every 12 hours for one month from Roozdaroo company
Intervention group 2: Capsule Clarithromycin 500 mg every 12 hours for one month from Tehran Shimi company
Control Group without Medication
Main outcome variables
Dyspnea, cough
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200718048129N1
Registration date:2020-08-11, 1399/05/21
Registration timing:prospective
Last update:2020-08-11, 1399/05/21
Update count:0
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
sima bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2267 8057
Email address
bahrami.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effectiveness of Hydroxychloroquin versus Clarithromycin in recovery of dyspnea and Caugh at the end of the acute phase of COVID-19 treatment
Public title
Evaluation of the effectiveness of Hydroxychloroquine and Clarithromycin in dyspnea and caugh caused by COVID-19 in recovery phase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with definitive diagnosis of COVID19 were hospitalized and treated
Patients with COVID19 who still have dyspena and cough two weeks after discharge from the hospital
Patients with COVID19 who continue to have lung involvement on CT SCAN two weeks after discharge
Exclusion criteria:
Patients with comorbidities such as chronic heart or lung disease before COVID19
The need for long-term use of drugs that have an irreversible interaction with the drugs used in the plan.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In our study, the simple randomization method is used as follows. A number of sealed envelopes in which study groups with letters A, intervention group with hydroxychloroquine, group B, intervention with clarithromycin and group C, including the control group, have been identified.The number of envelopes in each group is equal in number. The cards are merged and a card is randomly selected for each referring patient, thus assigning the patient to one of the groups. The removed card is then returned to the other cards. This process continues until a random sequence is reached according to the sample size in each group.
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
Floor5,Headquarters,Iran university of Medical science,between Chamran and sheikh Fazlollah,Hemmat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-07-04, 1399/04/14
Ethics committee reference number
IR.IUMS.FMD.REC.1399.244
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID19 ,virus identified
Primary outcomes
1
Description
Dyspnea
Timepoint
Beginning of the study (before the intervention), 14, 30 days after the start of the study
Method of measurement
Medical Research Council(MRC)
2
Description
cough
Timepoint
Beginning of the study (before the intervention), 14, 30 days after the start of the study
Method of measurement
visual analogue scale(vas)
Secondary outcomes
1
Description
lung function.
Timepoint
At the beginning of the study (before the intervention) and 30 days later at the end of the study
Method of measurement
six minute walk test(6MW)
Intervention groups
1
Description
Intervention group 1: Hydroxychloroquine tablets 200 mg every 12 hours for one month fram Rooz daroo company
Category
Treatment - Other
2
Description
Intervention group 2: Clarithromycin 500 mg capsules every 12 hours for one month from Tehran shimi company
Category
Treatment - Other
3
Description
Control group: without receiving medication during a one-month follow-up
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 provided data after unidentifying the subjects, include demographic information and characteristics of their disease in the acute phase, along with a description of the first visit and tests taken from patients at that time. The type of performed intervention for each patient and patients' clinical condition change after Intervention practices and finally the method of data analysis are the other documents which can be provided.
When the data will become available and for how long
Access started 6 months after the results were published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to conduct further research, any analysis other than those used in this study is acceptable with the permission of the research agent.
From where data/document is obtainable
Dr. Sima Bahrami
Address: Allergy and Immunology Clinic,Hazrat Rasoul Hospital, Niayesh St - Sattarkhan Av. Tehran
Phone: 09127305773
Email: bahrami.s@iums.ac.ir
What processes are involved for a request to access data/document
The applicant can introduce himself / herself by e-mail and provide sufficient and documented reasons for receiving the study information.The research agent can check this information in a period of two weeks and if he is sure that the request is correct, he will send the requested items to the applicant