v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04459702 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
drsabinehazan@progenabiome.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-07 |
|
Recruitment status
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
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, ambulant male or female subjects 18 years of age to 65 years of age positive test for covid-19 by rt-pcr at screening subjects must agree to practice at least one highly effective method of birth control for the duration of the study. this includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized) subjects must agree they will do their best to attend the treatment facility daily for 10 days |
|
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 > 38 degrees; pleuritic pain, or frequent cough. known drug allergy to any of the investigational medications currently taking medication with known drug interactions with investigational medications (listed in appendix) prescription or other antiviral medications any comorbidities which constitute health risk for the subject pregnant or lactating females; weight < 110lb; porphyria established retinal disease inability to attend daily for 10 days any contraindications for treatment with hydroxychloroquine hypoglycemia known g6pd deficiency porphyria anemia neutropenia alcoholism myasthenia gravis skeletal muscle disorders maculopathy changes in visual field liver disease psoriasis history of qt >500msec history of torsades de pointes anemia from pyruvate kinase and g6pd deficiencies abnormal ekg with qt prolongation acquired or from birth history of jaundice or high fevers prior to developing covid-19 treatment with any of the medications listed in appendix ii treatment with any anti-epileptic medication treatment with any other drug not listed that affects the qt interval |
|
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. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
65 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores;Efficacy of Treatment by Time to Non-Infectivity |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1536, "treatment_name": "Azithromycin+hydroxychloroquine+lopinavir+ritonavir", "treatment_type": "Antibiotics+antimalarials+antivirals", "pharmacological_treatment": "Pharmacological treatment"}] |