Protocol summary
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Study aim
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The effect of naproxen on the healing process of COVID-19 patients
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Design
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This double-blind clinical trial study has an intervention group and a control group with parallel and randomized groups, with a sample size of 80. A phase 2 study with block randomization.
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Settings and conduct
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The place of this study is in Ayatollah Taleghani Hospital in Abadan. In the patient control group, standard drugs use the national protocol + placebo (in terms of appearance and color similar to naproxen 500 mg every 12 hours for 5 days). In the intervention group, standard drugs of the national protocol + naproxen 500 mg every 12 hours are used for 5 days.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan
Having consent to participate in the intervention
Exclusion criteria: pregnant or breast feeding women Those taking losartan and captopril. Those with a history of intestinal ulcers or gastrointestinal bleeding. Children under 14 years
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Intervention groups
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Control group: Standard drugs of the national protocol (hydroxychloroquine sulfate 200mg, two single-dose tablets (Tehran Daru) , two single-dose tablets (Pars), Kaletra tablets (Lupinavir / Ritonavir) every 12 hours 2 tablets 50/200)+ A placebo every 12 hours (in terms of appearance and color similar to 500 mg naproxen).
Intervention Group: Standard Protocol Drugs For 5 days(Hydroxychloroquine Sulfate 200mg Two Single Dose tablets (Tehran Daroo) , Kaletra tablets (Lupinavir / Ritonavir) (Indian Ritcomum) every 12 hours, 2 tablets 50/200) + Naproxen 500 mg every 12 hours (Pars Daru) For 5 days
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Main outcome variables
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The recovery process of patients with Covid 19 (improvement of fever, chills, cough and night sweats)
General information
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Reason for update
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Edit publication list and date of recruitment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200324046850N3
Registration date:
2020-03-30, 1399/01/11
Registration timing:
prospective
Last update:
2020-05-18, 1399/02/29
Update count:
2
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Registration date
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2020-03-30, 1399/01/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-20, 1399/02/01
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Expected recruitment end date
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2020-05-20, 1399/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of naproxen on the healing process of patients with COVID-19
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Public title
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The effect of naproxen on the healing process of patients with COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan
Having consent to participate in the intervention
Exclusion criteria:
pregnant or breast feeding women
Those taking losartan and captopril.
Those with a history of intestinal ulcers or gastrointestinal bleeding.
Children under 14 years
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Age
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From 15 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, block randomization was performed using block size: 6. Allocation sequence and concealment codes are generated by www.sealedenvelope.com. The closed envelope method was used to hide the allocation sequence.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants and researchers in this study are blind, and the placebo used in the control group is the pill, which is similar in appearance and color to naproxen.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-18, 1398/12/28
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Ethics committee reference number
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IR.ABADANUMS.REC.1398.115
Health conditions studied
1
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Description of health condition studied
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corona virus disease
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ICD-10 code
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U07.2
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ICD-10 code description
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COVID-19, virus not identified
Primary outcomes
1
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Description
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Time to clinical improvement defined as start of taking medication time to the next 28 days.
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Timepoint
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The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
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Method of measurement
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Medical record
Secondary outcomes
1
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Description
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Duration of hospitalization
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Timepoint
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Time of discharge
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Method of measurement
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Number of hospital days
2
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Description
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Duration of stay at ICU
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Timepoint
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Daily
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Method of measurement
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Number of days of hospitalization in ICU
3
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Description
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Adverse events
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Timepoint
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Time of discharge
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Method of measurement
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Medical record
4
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Description
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laboratory variables (CBC, CRP, BUN, Cr, AST, ALT, ALK-ph, ESR, CPK)
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Timepoint
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The beginning of the study and the time of discharge
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Method of measurement
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Medical record
5
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Description
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Cough
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Timepoint
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The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
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Method of measurement
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Clinical observation and examination
6
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Description
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shortness of breath
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Timepoint
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The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
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Method of measurement
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Clinical observation and examination
7
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Description
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Fatigue
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Timepoint
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The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
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Method of measurement
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Clinical observation and Interview with the patient
8
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Description
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Diarrhea
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Timepoint
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The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
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Method of measurement
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Interview with the patient
9
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Description
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Body pain
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Timepoint
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The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
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Method of measurement
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Interview with the patient
10
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Description
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The patient's condition is based on inpatient or outpatient
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Timepoint
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The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day
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Method of measurement
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seven category ordinal scale
Intervention groups
1
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Description
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Control group: Standard drugs of the national protocol (hydroxychloroquine sulfate 200mg, two single-dose tablets (Tehran Daru) , two single-dose tablets (Pars), Kaletra tablets (Lupinavir / Ritonavir) every 12 hours 2 tablets 50/200)+ A placebo every 12 hours (in terms of appearance and color similar to 500 mg naproxen).
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Category
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Treatment - Drugs
2
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Description
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Intervention Group: Standard Protocol Drugs For 5 days (Hydroxychloroquine Sulfate 200mg Two Single Dose tablets (Tehran Daroo) , Kaletra tablets (Lupinavir / Ritonavir) every 12 hours, 2 tablets 50/200) + Naproxen 500 mg every 12 hours (Pars Daru) For 5 days
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Abadan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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-All data can be shared after the participants in the study are unrecognizable.
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When the data will become available and for how long
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The data access period after printing the article
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To whom data/document is available
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The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
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Under which criteria data/document could be used
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- Any analysis can be done with the consent of the main researcher.
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From where data/document is obtainable
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s.mobarak@abadanums.ac.ir
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What processes are involved for a request to access data/document
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-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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Comments
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