Status:
UNKNOWN
An Outpatient Clinical Trial Using Ivermectin and Doxycycline in COVID-19 Positive Patients at High Risk to Prevent COVID-19 Related Hospitalization
Lead Sponsor:
Max Health, Subsero Health
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this Clinical trial is to explore the therapeutic benefits of Ivermectin and Doxycycline in different combinations in high risk patients diagnosed with COVID-19.
Detailed Description
Purpose of the study: The purpose of this Clinical trial is to explore the therapeutic benefits of Ivermectin and Doxycycline in different combinations. The investigators are studying known medicatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04729140
Start Date
December 28 2020
End Date
March 28 2022
Last Update
April 1 2021
Active Locations (1)
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1
MAX HEALTH, Subsero Health 2055 Wood Street, Suite 100
Sarasota, Florida, United States, 34237