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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04482686 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 28, 2021, 11 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 28, 2021, 11 a.m. Source : ClinicalTrials.gov |
drsabinehazan@progenabiome.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-22 |
|
Recruitment status
Last imported at : Oct. 28, 2021, 11 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study healthy male or female subjects at least 18 years of age diabetic and obese (bmi > 30) patients will be included in the trial but randomization will be stratified. positive test for covid-19 by rt-pcr or rapid antigen test at screening subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. one of these must be a barrier method. exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal) subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
refusal to sign informed consent form negative test for covid-19 by rt-pcr at screening severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 104.0 degrees f, pleuritic pain, or frequent cough. known drug allergy to any of the investigational medications currently taking medication with known drug interactions with investigational medications, found in appendix ii prescription or other antiviral medications any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine inability to attend daily for 10 days |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
ProgenaBiome |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 28, 2021, 11 a.m. Source : ClinicalTrials.gov |
75 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Oct. 28, 2021, 11 a.m. Source : ClinicalTrials.gov |
31 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Time to Non-Infectivity by RT-PCR;Efficacy of Treatment as measured by RT-PCR;Efficacy of Treatment as measured by Titer;Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score);Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1488, "treatment_name": "Doxycycline+ivermectin", "treatment_type": "Antibiotics+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |