Investigating the efficacy and safety of Hydroxychloroquine nasal spray in controlling the symptoms of patients with COVID-19
Design
This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
Settings and conduct
Patients who is admitted to Baqiyatallah hospital, and is meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms.
Exclusion criteria: history of allergy to ingredients; hypersensitivity reaction while taking this spray; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unit.
Intervention groups
Intervention group: Hydroxychloroquine nasal spray (500µg/dose) 1 puff in each nostril every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus).
Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus.
Investigating the efficacy and safety of Hydroxychloroquine nasal spray in controlling the symptoms of patients with COVID-19
Public title
Investigating the efficacy and safety of Hydroxychloroquine nasal spray in controlling the symptoms of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to this nasal spray ingredients;
Hypersensitivity reaction while taking this nasal spray;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients.
In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants 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 Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.BMSU.REC.1399.091
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Clinical symptoms (dry cough)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Physical examination,questionnaire
2
Description
Clinical symptoms (respiratory distress)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Pulse-oxymetery device
3
Description
Clinical symptoms (fever)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Thermometer
Secondary outcomes
1
Description
Lab. tests changes
Timepoint
Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
Method of measurement
Blood sample, laboratory analysis
2
Description
Side effects
Timepoint
Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Hydroxychloroquine nasal spray (500μg/dose) 1 puff in each nostril every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus)
Category
Treatment - Drugs
2
Description
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.