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Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection (US)

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ClinicalTrials.gov Identifier: NCT05074394
Recruitment Status : Not yet recruiting
First Posted : October 12, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: COVI-DROPS Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal STI-2099 (COVI-DROPS™) as Treatment for COVID-19 Infection in Outpatient Adults
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: COVI-DROPS
40 mg of COVI-DROPS administered intranasally
Biological: COVI-DROPS
COVI-DROPS is a fully human monoclonal antibody that is a neutralizing antibody to SARS-CoV-2
Other Name: STI-2099

Placebo Comparator: Placebo
2 mL placebo administered intranasally
Drug: Placebo
Diluent solution




Primary Outcome Measures :
  1. Proportion of subjects who have a COVID-19-related visit or hospitalization [ Time Frame: Baseline through Day 29 ]
    Proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through Day 29 (D29)


Secondary Outcome Measures :
  1. Viral load change from baseline to Day 15 (D15) [ Time Frame: Baseline through Day 15 ]
    Viral load change from baseline to D15 based on nasal quantitative reverse transcription polymerase chain reaction (RT-PCR) COVID-19 viral titers (Log-10 copies/mL). Includes viral load change for subjects in the unvaccinated/no prior infection group as well as the vaccinated/prior infection group

  2. Proportion of subjects who have a COVID-19-related visit or hospitalization based on stratification groups [ Time Frame: Baseline to Day 29 ]
    For each of the unvaccinated/no prior infection group or the vaccinated/prior infection group, proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through D29



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074394


Contacts
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Contact: Mike Royal, MD (858)203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05074394    
Other Study ID Numbers: DRP-COV-206US
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
COVID19
COVID-19
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases