Protocol summary
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Study aim
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Comparison of the administration of vitamin D3 and N acetylcysteine tablets in COVID-19 patients and their effect on recovery
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Design
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This study will be conducted on randomized, double-blind, phase 3 clinical trials in 100 patients. Randomization method is block randomization and block size was 8 and 4.
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Settings and conduct
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This randomized, double-blind clinical trial is being conducted at Ayatollah Taleghani Hospital in Abadan. The study was performed on 100 patients with COVID-19 who were admitted to the infectious disease ward of Ayatollah Taleghani Hospital. A written consent was obtained for this study. In this study participants, researchers and outcome assessment are blind.
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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 for COVID-19.
Exclusion criteria: Pregnant or breast feeding women, Patients under 18 years of age, Any life-threatening factor
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Intervention groups
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Note: standard country protocol drugs (lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours + hydroxychloroquine (200 mg) two tablets one dose).
The first group: Patients receiving standard country protocol drugs with vitamin D3 ampoules of 50,000 units once a week and N-acetylcysteine placebo tablets every 12 hours
The second group: Patients receiving standard country protocol drugs with 600mg N-acetylcysteine tablet every 12 hours and vitamin D3 placebo once a week
The third group: Patients receiving standard country protocol drugs with 600mg N-acetylcysteine tablets every 12 hours and 500,000 units of vitamin D3 once a week
The fourth group: Patients receiving standard country protocol drugs with placebo vitamin D3 once a week and placebo tablets N-acetylcysteine every 12 hours
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Main outcome variables
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Time to clinical improvement defined as start of taking medication time to Discharge Time.
General information
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Reason for update
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Update patient history and edit data list editing
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200324046850N1
Registration date:
2020-03-29, 1399/01/10
Registration timing:
prospective
Last update:
2020-06-03, 1399/03/14
Update count:
1
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Registration date
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2020-03-29, 1399/01/10
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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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2020-06-06, 1399/03/17
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Expected recruitment end date
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2020-07-07, 1399/04/17
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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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Comparison of vitamin D3 and N-acetylcysteine prescription in COVID19 patients and their effect on recovery process
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Public title
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Comparison of vitamin D3 and N-acetylcysteine prescription in COVID-19 patients and their effect on recovery process
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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 for COVID-19.
Exclusion criteria:
Pregnant or breast feeding women
Patients under 18 years of age
Any life-threatening factor
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Age
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From 18 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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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. 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.
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Placebo
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Used
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Assignment
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Factorial
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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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2020-03-17, 1398/12/27
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Ethics committee reference number
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IR.ABADANUMS.REC.1398.118
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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Other coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
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Description
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Time to clinical improvement defined as start of taking medication time to Discharge Time.
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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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Complete Blood Count
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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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blood sample
2
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Description
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Venous blood gas
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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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Blood sample
3
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Description
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C-reactive-protein
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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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Blood sample
4
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Description
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creatinne
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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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Blood sample
5
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Description
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Aspartate amino transferase
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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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Blood sample
6
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Description
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Alanine amino transferase
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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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Blood sample
7
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Description
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Prothrombin time
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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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Blood sample
8
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Description
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Partial Thromboplastin time
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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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Blood sample
9
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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
10
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Description
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level of consciousness
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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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Using the Glasgow Coma scale
11
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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
12
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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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Observation and Interview with the patient
13
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Description
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Severe and frequent 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
14
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Description
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abdominal 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
15
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Description
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nausea and vomiting
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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
16
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Description
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Olfactory disturbances
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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
17
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Description
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Appetite
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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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Observation and Interview with the patient
18
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Description
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Duration of ICU stay
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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
19
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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
20
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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
21
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Description
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Mortality rate
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Timepoint
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Daily
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Method of measurement
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Medical record
22
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Description
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Taste disturbances
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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
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
3
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Description
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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
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Category
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Treatment - Drugs
4
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Description
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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
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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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No
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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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