A phase 1b/2a Study in Participants with Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Investigational Product Administered by Inhalation.
Eighteen Years and Older
Total Duration is 28 Days
$80 Per Visit
Patients who screen and then enroll in the study will receive:
- Doctor Assessments
- Lab work and Safety Follow-ups
- Study drug (active or placebo)
* For time and travel compensation per completed study visit.
Study Duration for Patients
The total study duration is 28-days which consists of approximately 7 visits during the course of the study.
The study consists of three periods:
- Screening Period (0-1 Day) to see if you are eligible to participate in the study.
- Study Treatment Period (5 Days). This Study Treatment period includes a 5-day double-blind study treatment Period.
- Safety Follow-Up (up to 23 days after the last dose of study drug) Safety follow-up to ensure all patients are safe.
The study may also have some unplanned visits, most commonly for repeat lab work.
600 Aviator Ct.
Vandalia, OH 45377
The following must be met in order to qualify for the study.
- At least 18 years of age
- Diagnosis of COVID-19 confirmed by polymerase chain reaction (PCR) ≤ 4 days prior to randomization
- Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization (fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia)
- Oxygen saturation as measured by pulse oximetry (SpO2) > 94% on room air
Patients with any of the following are ineligible to enroll in the study.
- Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19
- Prior or current hospitalization for COVID-19 or need for hospitalization
- Concurrent or planned treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including intravenous (IV) remdesivir (RDV)
- Requiring oxygen supplementation
- Positive pregnancy test
- Breastfeeding female
- Known hypersensitivity to the study treatment, its metabolites, or formulation excipient
- Pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma (Parts A and B only)
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
Joseph Allen, M.D.
Dr. Allen is a family practice physician with a passion for medicine and clinical research. His widespread community involvement and public recognition has enabled Dr. Allen to establish a substantial and growing practice. Dr. Allen treats patients of all ages from pediatrics to geriatrics. He also studied and continues to work in sports medicine and is a volunteer for local schools. Dr. Allen’s close professional relationships with numerous colleagues provides timely access to professional opinions and referrals.