randomized study to evaluate intranasal dose of sti-2099 (covi-drops™) in outpatient adults with mild covid-19 infection

Conditions: COVID-19

Summary: this is prospective double-blind study in the united states is designed to investigate the efficacy and safety of a single dose of covi-drops or matched placebo in outpatient adults with mild symptoms associated with covid-19 and a recent positive covid-19 test.

subjects will be randomized 2:1 to receive a single dose of covi-drops (40 mg) or placebo in a double-blind manner. investigational product (covi-drop or placebo) will be administered once on study day 1 and followed to day 29. subjects will be stratified based upon prior history of infection or vaccination versus the group who is unvaccinated and not previously infected with covid-19.

Eligibility criteria:
inclusion criteria: * positive for covid-19 with any approved rt-pcr or rapid antigen test within 7 days of planned treatment * have mild illness/symptoms based upon nih criteria. the nih illness severity definition for "mild" states as follows: "individuals who have any of the various signs and symptoms of covid-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging." * be in good health as judged by investigator using screening medical history and physical examination. participants who are otherwise healthy with a stable chronic medical condition may enroll * a prior covid-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous covid-19 vaccination * must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol * subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity * willing to follow contraception guidelines exclusion criteria: * in the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) * currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to covid-19 infection * is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection * has an active documented infection other than covid-19 * any medical condition that, in the investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process * pregnant or lactating women who are breast feeding or planning on either during the study * has received within the 30 days prior to screening or is planning on receiving an eua-cleared monoclonal antibody (mab) during the study * has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, other non-eua-cleared mabs against covid-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Keywords: covid19 covid-19