Trials Sponsors Conditions Drugs Pricing

Conditions

SARS-CoV-2 (COVID-19)

Outcome Measures

Primary Outcomes (1)

To evaluate the safety of 2-dose vaccination schedule of orally administered CoV2-OGEN1 by following local and systemic adverse events
Solicited local and systemic adverse events (may include Gi Disturbance)-Potential systemic events may include fever, fatigue, headache and chills following vaccination. Potential local events may include nausea, vomiting, diarrhea, and gastrointestinal discomfort following vaccination.
Non serious AE are to assessed for 21-28 days after each study vaccination while serious AE are to be followed for atleast 6 months after completion of all study vaccinations

Secondary Outcomes (6)

To evaluate geometric mean fold rise (GMFR)
From baseline on day 43
To evaluate geometric mean fold rise (GMFR)
From baseline on day 43
To evaluate geometric mean fold rise (GMFR)
From baseline on day 43
To evaluate geometric mean titer (GMT)
On day 43
To evaluate geometric mean titer (GMT)
On day 43
+1 more secondary outcomes

Study Arms (1)

Orally administered CoV2-OGEN1- 2 dose schedule

EXPERIMENTAL

50mcg,100mcg and 200mcg will be tested as single oral dose on day 1 and day 15. The dose will be in the form of oral suspension.

Drug: Orally Suspension of CoV2-OGEN1

Interventions

Orally Suspension of CoV2-OGEN1Drug

CoV2-OGEN1 will be supplied as a 10mL oral suspension in a plastic bottle containing 50-200 mcg of formulated drug

Orally administered CoV2-OGEN1- 2 dose schedule

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 56 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Participants must fulfil all of the following criteria to be eligible for the study:
Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol and be available for all study visits.

Sponsors & Collaborators

US Specialty Formulations, LLC
Type not reportedcollaborator
Syneos Health
Otherlead

Study Sites (1)

Auckland Clinical Studies Ltd (NZCR OpCo Limited)

Grafton, Auckland, 1010, New Zealand

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 19, 2021

Study Start

June 30, 2021

Actual (reported)

Primary Completion

You may not qualify if:

Participants will be excluded from participation in the study if any of the following criteria are met at screening:
Positive pregnancy test either at screening or just prior to the first vaccine administration.
Participants who is breastfeeding or planning on breastfeeding from the time of the first vaccination through 60 days after the last vaccination.
Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
Acute or chronic gastrointestinal conditions such as Crohn's, Ulcerative Colitis, gastritis, proctitis, IBS, or any other inflammatory bowel disease.
Currently taking Histamine-2 (H2) Blocker, Proton Pump Inhibitor (PPI), Promotility Agent, or any chronic antacids.
Presence of self-reported or medically documented significant medical or psychiatric condition(s).
Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), uncontrolled hypertension, history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia.
Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease).
Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
Active autoimmune disease or any history of autoimmune disease determined by hx or lab/physical examination.
Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
T2DM
Asthma
Respiratory conditions (including emphysema or COPD)
+25 more criteria

First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Orally administered CoV2-OGEN1- 2 dose schedule

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Orally administered CoV2-OGEN1- 2 dose schedule

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations