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| Column | Value |
|---|---|
| Trial registration number | NCT04729140 |
|
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
ibedi@mymaxdoc.com |
|
Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-01-28 |
|
Recruitment status
Last imported at : March 14, 2023, midnight Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 29, 2021, 12:31 a.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 : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - age greater than or equal to 18 - willing and able to provide verbal /telephonic/personal or computer based informed consent - experiencing symptoms of covid-19 illness and tested positive for sars cov-2 with either pcr, naat or antigen testing - residents in a nursing home or long-term care facility - immunocompromised state, including solid organ transplant, hiv infection, other immune deficiency, immunosuppressant medication including systemic corticosteroids - chronic lung disease, including chronic obstructive pulmonary disease (copd), moderate to severe asthma, cystic fibrosis, pulmonary fibrosis - cardiovascular disease - cancer - hypertension - obesity (body mass index [bmi greater then or equal to 30 kg/m^2] - diabetes mellitus - chronic kidney disease - chronic liver disease - cerebrovascular disease - neurological disorders including dementia - tobacco use disorders - hematologic disorders, including sickle cell disease and thalassemia we are also interested in including a vital population to protect, considered essential workers who may not fit into the above inclusion criteria: - health care professionals and firefighters. - government officials or employees. - students and teachers. - law enforcement agents and personnel. - individuals who live with, and cannot isolate, from any of the above groups. |
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Exclusion criteria
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- participants under the age of 18 - received any covid vaccine within the last 30 days - contraindications to ivermectin or doxycycline - history of seizure disorder or epilepsy - history of myocardial infarction or heart attack within the last one month - already receiving ivermectin or doxycycline for treatment of any other disease or disorder - allergies to ivermectin or doxycycline including angioedema, severe asthma, exfoliative dermatitis, steven jonson syndrome or psoriasis - history of angioedema, exfoliative dermatitis, steven johnson syndrome, psoriasis - currently pregnant or planning to conceive soon - breastfeeding - history of prior clostridium difficile infection |
|
Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Max Health, Subsero Health |
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Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
150 |
|
primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Decreased admission rate to the hospital secondary to respiratory illness related to COVID-19 |
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Notes
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 418, "treatment_name": "Doxycycline", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |