| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19) |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 23.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10084401 |
| E.1.2 | Term | COVID-19 respiratory infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 23.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10084268 |
| E.1.2 | Term | COVID-19 |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
Safety (Part A)
To evaluate the safety and tolerability profile of intravenous (IV) VIR-7831 Gen2 and IV Gen1
Pharmacodynamics (Part B)
To evaluate the virological response of VIR-7831 Gen2 administered IV and via intramuscular (IM) injection in the upper respiratory tract
|
|
| E.2.2 | Secondary objectives of the trial |
Safety (Part A)-To evaluate the safety and tolerability profile of IV VIR-7831 Gen2 and IV Gen1
Safety (Part B)-To evaluate the safety and tolerability profile of VIR-7831 Gen2 administered via IV infusion and IM injection, through Day 29
Virology (Part B)-To characterize the effect of VIR-7831 Gen2 IV and IM on viral load clearance in the upper respiratory tract
Pharmacokinetics (Part A and Part B)-To assess the pharmacokinetics (PK) of VIR-7831 Gen2 IV and IM and Gen1 IV in serum
Safety (Part B)-To evaluate the safety and tolerability profile of VIR-7831 Gen2 administered via IV infusion and IM injection, through End of Study (EOS)
Virology (Part A)-To characterize the effect of VIR-7831 Gen2 IV and Gen1 IV on the viral shedding profile in the upper respiratory tract
Virology (Part B)-To characterize the effect of VIR-7831 Gen2 IV and Gen2 IM on the viral shedding profile in the upper respiratory tract
Refer Protocol, for other Secondary Objective. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
Part A: Participant must be aged 18 years or older at the time of obtaining informed consent.
Part B: Participant must be aged ≥18 years to <70 years at the time of obtaining informed consent. The additional age restriction of <70 years for Part B is for logistical purposes such that this study and the COMET-TAIL study,(a study administering VIR-7831 via IM injection for which planning is currently ongoing), which are enrolling similar populations (non-hospitalized patients with mild to moderate COVID-19), can utilize many of the same sites for participant enrollment. The
COMET-TAIL study, which requires that a participant is at high risk for progression to severe disease and/or ≥55 years of age, will be enriching enrollment for participants ≥70 years of age or older.
Type of Participant and Disease Characteristics
2.Participants who have a positive SARS-CoV-2 test result (by any validated test e.g. RT-PCR on any respiratory type)≤ 7 days prior to enrollment
AND
Oxygen saturation ≥94% on room air
AND
Have COVID-19 defined by one or more of the following symptoms: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhea, shortness of breath on exertion
AND
≤7 days from onset of symptoms
Sex and Contraceptive/Barrier Requirements
3.No gender restrictions
4.Female participants must meet and agree to abide by the following contraceptive criteria. Contraception use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
a.Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4 of protocol
OR
b.Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 of the protocol during the study intervention period and for up to 24 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. See Section 8.4.7 Pregnancy Testing of the protocol.
-If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
-Additional requirements for pregnancy testing during and after study intervention are located in Section 1.3 of the protocol.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Informed Consent
5.Capable of giving signed informed consent as described in Section 10.1.3 of protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
OR
If participants are not capable of giving written informed consent, alternative consent procedures will be followed as described in Section 10.1.3 of protocol |
|
| E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1.Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours.
2.Symptoms consistent with severe COVID-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen.
3.Participants who, in the judgement of the investigator are likely to die in the next 7 days.
4.Severely immunocompromised participants including but not limited to cancer patients receiving immunosuppressive chemotherapy or immunotherapy, those with a solid organ transplant or allogeneic stem cell transplant within the last 3 months, any history of heart or lung transplant or high dose long-term systemic corticosteroids (equivalent to ≥20 mg a day of prednisone or the systemic equivalent for over 2 weeks).
5.Known hypersensitivity to any constituent present in the investigational product.
6.Previous anaphylaxis or hypersensitivity to a monoclonal antibody.
7.For Part B of the study – Participant has any condition that would prohibit receipt of intramuscular injections in the investigator’s opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia
Prior/ Concurrent Clinical Study Experience
8.Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer.
9.Enrollment in any trial of an investigational vaccine for SARS-CoV-2.
Other Exclusions
10.Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not be allowed for 90 days after dosing.
11.Receipt of convalescent plasma from a recovered COVID-19 patient or anti SARS-CoV-2 mAb within the last 3 months.
12.Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through Day 29.
13. Participants of legal age who are incapable of comprehending the nature, significance and implications of the clinical trial according to §41 paragraph 3 no. 3, according to German Medicinal Products Act (AMG).
14. Participants who have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, according to
§40 paragraph 1 sentence 3 no. 4, German Medicinal Products Act (AMG).
15. Participants must not be in a dependent relationship with the site, investigator or sponsor, according to §40 paragraph 1 sentence 3 no. 3 letter b) and c), German Medicinal Products Act (AMG). |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
•Occurrence of adverse events (AEs) through Day 29
•Occurrence of serious adverse events (SAEs) through Day 29
•Occurrence of adverse events of special interest (AESIs) through Day 29
•Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings through Day 29
•Occurrence of disease progression events (not classified as AEs) through Day 29
•Mean area under the curve (AUC) of SARS-CoV-2 viral load as measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 (AUCD1-8) in nasopharyngeal swab samples |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Refer E.5.1 for Timepoints |
|
| E.5.2 | Secondary end point(s) |
•Occurrence of non-serious AEs through Week 12
•Occurrence of SAEs through Week 24
•Occurrence of AESIs through Week 24
•Occurrence of clinically significant abnormalities on 12-lead ECG readings through Week 12
•Occurrence of disease progression events (not classified as AEs) through Week 24
•Occurrence of adverse events (AEs) through Day 29
•Occurrence of serious adverse events (SAEs) through Day 29
•Occurrence of adverse events of special interest (AESIs) through Day 29
•Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings through Day 29
•Occurrence of disease progression events (not classified as AEs) through Day 29
•Occurrence of non-serious AEs through Week 12
•Occurrence of SAEs through Week 24
•Occurrence of AESIs through Week 24
•Occurrence of clinically significant abnormalities on 12-lead ECG readings through Week 12
•Occurrence of disease progression events (not classified as AEs) through Week 24
•Change from baseline in viral load at all visits through Day 29 as measured by qRT-PCR from saliva and nasal mid-turbinate swabs samples
•Change from baseline in viral load at all visits through Day 29 as measured by qRT-PCR from nasopharyngeal (NP) swab samples
•Proportion of participants with undetectable viral load at all visits through Day 29 of the study as measured by qRT-PCR from NP swab samples
•Mean area under the curve of SARS-CoV-2 viral load as measured by qRT-PCR from Day 1 to Day 5 (AUCD1-5) and Day 1 to 11 (AUCD1-11)
•Proportion of individuals with a persistently high viral load at Day 8 as assessed via qRT-PCR in NP swab samples (see Section 8.3 of protocol)
•Serum PK of VIR-7831
•Emergence of SARS-CoV-2 viral resistance mutants
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Refer E.5.2 for Timepoints |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Part A for PR1 & PR2, Part B for PR2 & PR3 |
|
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 8 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Canada |
| Korea, Republic of |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| A participant is considered to have completed the study if he/she has completed all phases of the respective part of the study to which he/she was enrolled (Part A or Part B) through to Week 24 follow up. The end of the study is defined as the date of the last contact of the last participant in the study. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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