]>
IRCT20200324046850N1 IRCT 2020-03-29 Abadan University of Medical Sciences Comparison of vitamin D3 and N-acetylcysteine prescription in COVID-19 patients and their effect on recovery process Comparison of vitamin D3 and N-acetylcysteine prescription in COVID19 patients and their effect on recovery process 2020-06-06 anticipated 100 Complete https://irct.ir/trial/46732 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: This study will be a randomized, double-blind, phase 3 clinical trials on 100 patients. Randomization method is block randomization and block size was 8 and 4. Randomization sequence and concealment codes will de created by www.sealedenvelope.com website. Sealed envelopes were used for allocation concealment, Blinding description: . In this study participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance, So patients do not understand which group they are in. Sealed envelopes were used for allocation concealment. 3 Covid-19. Intervention 1: Intervention group 1: Patients receiving standard country protocol drugs(lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with vitamin D3 ampoules of 50,000 units once a week and N-acetylcysteine placebo tablets every 12 hours. Intervention 2: Intervention group 2: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablet every 12 hours and vitamin D3 placebo once a week. Intervention 3: Intervention group 3: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablets every 12 hours and 500,000 units of vitamin D3 once a week. Intervention 4: Intervention group 4: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with placebo vitamin D3 once a week and placebo tablets N-acetylcysteine every 12 hours. 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) 6313833177 +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 for COVID-19. 18 years no limit Both Pregnant or breast feeding women Patients under 18 years of age Any life-threatening factor U07.1 Other coronavirus as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients receiving standard country protocol drugs(lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with vitamin D3 ampoules of 50,000 units once a week and N-acetylcysteine placebo tablets every 12 hours Intervention group 2: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablet every 12 hours and vitamin D3 placebo once a week Intervention group 3: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with 600mg N-acetylcysteine tablets every 12 hours and 500,000 units of vitamin D3 once a week Intervention group 4: Patients receiving standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose) with placebo vitamin D3 once a week and placebo tablets N-acetylcysteine every 12 hours Time to clinical improvement defined as start of taking medication time to Discharge Time. 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. Complete Blood Count. Timepoint: The beginning of the study and the time of discharge. Method of measurement: blood sample. Venous blood gas. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample. C-reactive-protein. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample. Creatinne. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample. Aspartate amino transferase. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample. Alanine amino transferase. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample. Prothrombin time. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample. Partial Thromboplastin time. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Blood sample. 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. Level of consciousness. Timepoint: The beginning of the study ,the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Using the Glasgow Coma scale. 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: Observation and Interview with the patient. Severe and frequent 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. Abdominal 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. Nausea and vomiting. 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. Olfactory disturbances. 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. Appetite. Timepoint: The beginning of the study, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day. Method of measurement: Observation and Interview with the patient. Duration of ICU stay. Timepoint: Daily. Method of measurement: Number of days of hospitalization in ICU. Adverse events. Timepoint: Time of discharge. Method of measurement: Medical record. 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. Mortality rate. Timepoint: Daily. Method of measurement: Medical record. Taste disturbances. 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. Abadan University of Medical Sciences Approved 2020-03-17 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)