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IRCT20200324046850N3 IRCT 2020-03-30 Abadan University of Medical Sciences The effect of naproxen on the healing process of patients with COVID-19 The effect of naproxen on the healing process of patients with COVID-19 2020-04-20 anticipated 80 Complete https://irct.ir/trial/46718 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 corona virus disease. Intervention 1: 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 2: 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. Yes - There is a plan to make this available What will be shared: -All data can be shared after the participants in the study are unrecognizable. When: The data access period after printing the article To whom: The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration. Conditions: - Any analysis can be done with the consent of the main researcher. Where to obtain: s.mobarak@abadanums.ac.ir How to obtain: -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. Comments:
public Sara Mobarak
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
Abadan Iran (Islamic Republic of) 631911154 +98 61 5338 4004 s.mobarak@abadanums.ac.ir Abadan University of Medical Sciences scientific Sara Mobarak
Abadan School of Medical Sciences, Beginning of the 30 meters Ave, Zolfaghari street, Abadan city
Abadan Iran (Islamic Republic of) 631911154 +98 61 5338 4004 s.mobarak@abadanums.ac.ir Abadan University of Medical Sciences Iran (Islamic Republic of) COVID-19 patients that have positive PCR test of nasopharyngeal sample or have positive CT Scan Having consent to participate in the intervention 15 years no limit Both pregnant or breast feeding women Those taking losartan and captopril. Those with a history of intestinal ulcers or gastrointestinal bleeding. Children under 14 years U07.2 COVID-19, virus not identified Treatment - Drugs Treatment - Drugs 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) every 12 hours, 2 tablets 50/200) + Naproxen 500 mg every 12 hours (Pars Daru) For 5 days Time to clinical improvement defined as start of taking medication time to the next 28 days. Timepoint: The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Medical record. Duration of hospitalization. Timepoint: Time of discharge. Method of measurement: Number of hospital days. Duration of stay at ICU. Timepoint: Daily. Method of measurement: Number of days of hospitalization in ICU. Adverse events. Timepoint: Time of discharge. Method of measurement: Medical record. Laboratory variables (CBC, CRP, BUN, Cr, AST, ALT, ALK-ph, ESR, CPK). Timepoint: The beginning of the study and the time of discharge. Method of measurement: Medical record. Cough. Timepoint: The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Clinical observation and examination. Shortness of breath. Timepoint: The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Clinical observation and examination. Fatigue. Timepoint: The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Clinical observation and Interview with the patient. Diarrhea. Timepoint: The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Interview with the patient. Body pain. Timepoint: The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Interview with the patient. The patient's condition is based on inpatient or outpatient. Timepoint: The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: seven category ordinal scale. Abadan University of Medical Sciences Approved 2020-03-18 Ethics Committee of Abadan School of Medical Sciences Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city. Abadan Khouzestan Iran (Islamic Republic of)