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Column | Value |
---|---|
Trial registration number | CTRI/2020/06/026192 |
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44815 |
First author
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
Contact
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
rranjesh@orphan-reach.com |
Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2020-06-28 |
Recruitment status
Last imported at : Nov. 6, 2020, 11:45 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not recruiting |
Study design
Last imported at : Nov. 18, 2021, 7:33 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : Nov. 18, 2021, 7:33 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
Center
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
multi-center |
Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1) Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure. <br/ >2) Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test less than 4 days before Visit 1 with signs of an acute respiratory infection. <br/ >3) Age more than equal to 18 and less than equal to 70 years. <br/ >4) CRP more than 50 and less than 150 mg/l. <br/ >5) Admitted to a hospital or controlled facility (home quarantine is not sufficient) <br/ >6) In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol. |
Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1) Any previous experimental treatment for COVID-19 <br/ >2) Need for mechanical invasive or non-invasive ventilation <br/ >3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis <br/ >4) Participation in any other interventional trial within 3 months prior to Visit 1 <br/ >5) Any of the following findings at Visit 1: <br/ >a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab) <br/ >b Positive pregnancy test (see Section 8.2.3). <br/ >6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator <br/ >7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial <br/ >8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I <br/ >9) Treatment with any of the medications listed below within 1 week prior to Visit 1: <br/ >a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates) <br/ >b. Warfarin <br/ >10) Pregnant or breast-feeding female subjects <br/ >11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 <br/ >12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1 <br/ >13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder). |
Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2 |
Funding
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Vicore Pharma AB |
Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
70 |
Countries
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
India;Russia;Ukraine;United Kingdom |
Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Moderate disease at enrollment |
Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
3: Moderate disease at enrollment |
Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
100 |
primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.).Timepoint: The primary endpoint will be the change in CRP from baseline to the average of the last 2 assessments during the treatment period. |
Notes
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
| Declared number of arm (2.0) differs from found arms (3.0) |
Phase
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Phase 2 |
Arms
Last imported at : Nov. 26, 2021, 10:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "", "treatment_id": 243, "treatment_name": "C21", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |