Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (STAMP)
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| ClinicalTrials.gov Identifier: NCT04805671 |
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Recruitment Status :
Terminated
(All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.)
First Posted : March 18, 2021
Results First Posted : February 6, 2024
Last Update Posted : February 6, 2024
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Sponsor:
Invivyd, Inc.
Information provided by (Responsible Party):
Invivyd, Inc.
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Brief Summary:
This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: ADG20 Drug: Normal saline | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 399 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, double-blind, placebo controlled |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The investigator, participant and sponsor personnel involved in study intervention and study evaluation will be unaware of the intervention assignments. Investigators will remain blinded to each participant's assigned study treatment throughout the course of the study. |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP) |
| Actual Study Start Date : | July 26, 2021 |
| Actual Primary Completion Date : | February 10, 2022 |
| Actual Study Completion Date : | November 3, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
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Experimental: ADG20 IM
Participants will be dosed on Day 1 with ADG20 IM
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Drug: ADG20
Single dose of ADG20 |
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Placebo Comparator: Placebo IM
Participants will be dosed on Day 1 with placebo IM
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Drug: Normal saline
Single dose of normal saline |
Primary Outcome Measures :
- Incidence of COVID-19 Related Hospitalizations or All-cause Death [ Time Frame: Through Day 29 ]To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID-19 in participants at high risk of disease progression. Hospitalization is defined as ≥24 hours of acute care in a hospital or acute care facility (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities). All-cause death is defined as death for any reason from Day 1 (postdose) through Day 29.
- Incidence of Treatment-emergent Adverse Events [ Time Frame: Through day 29 ]Proportion of participants with at least one treatment emergent AE
- Incidence of Solicited Injection Site Reactions [ Time Frame: Through Day 4 ]Proportion of participants with at least one solicited injection site reaction
- Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation) [ Time Frame: Through Day 29 ]Proportion of participants with a potentially clinically significant change from baseline in post-baseline laboratory parameters - data presented for any analyte with >/= 2% in any arm
- Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure) [ Time Frame: Through Day 29 ]Participants with Potentially Clinically Significant Changes (PCS) From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure) at Any Time Post-Baseline
Secondary Outcome Measures :
- Incidence of COVID-19 -Related Medically Attended Visits or All-cause Death [ Time Frame: Through Day 29 ]Proportion of participants with COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29. In addition to events defined as the primary efficacy endpoint, this endpoint also includes any medically attended visits, in-person, or telemedicine, not specified in the protocol. These include unscheduled in-person or telemedicine visits conducted by the investigator for the purpose of evaluating worsening signs or symptoms attributed to COVID-19 or emergency room, urgent care center or physician office visits, or hospitalization for attention to worsening signs or symptoms attributed to COVID-19, in the opinion of the investigator. Incidence of COVID-19-related medically attended visits or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.
- Incidence of COVID-19 -Related Emergency Room Visits, COVID-19-related Hospitalization, or All Cause-death [ Time Frame: Through Day 29 ]Proportion of participants with any COVID 19-related emergency room visits, COVID-19-related hospitalization, or all cause death through Day 29. Defined as any stay in a hospital or acute care facility regardless of duration (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities) for attention to worsening signs or symptoms attributed to COVID-19 in the opinion of the investigator or all cause death through Day 29. Incidence of COVID-19-related emergency room visits, COVID-19-related hospitalization, or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.
- Incidence of Severe/Critical COVID-19 or All Cause Death [ Time Frame: Through Day 29 ]Proportion of participants with Severe/Critical COVID-19 or all-cause death through Day 29. All-cause death is defined as death for any reason (from Day 1postdose) through Day 29. Severity is based on the investigator's assessment of severity (eCRF COVID-19 Severity Assessment) per the protocol definitions. Incidence of Severe/Critical COVID-19 or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.
- Time to Sustained Recovery Defined as Sustained Improvement or Resolution of COVID-19 Symptoms [ Time Frame: Through Day 29 ]Time to sustained recovery (improvement or resolution) of COVID-19 symptoms through Day 29: Defined as the time from the first dose date to the earliest date when sustained improvement or sustained resolution of COVID-19 symptoms is met (as detailed below) through Day 29. COVID-19 symptoms assessed include fever, chills, cough, sore throat, congestion, shortness of breath/difficulty breathing at rest, shortness of breath/difficulty breathing with exertion, muscle or body aches, fatigue, headache, nausea, vomiting, and diarrhea. Loss of taste/smell is excluded from this analysis.
- Incidence of All-cause Mortality [ Time Frame: Through Day 90 ]Defined as death for any reason from Day 1 (postdose). In the overall survival analysis, participants who are alive or lost to follow-up at the time of analysis are censored at the date of last contact.
- Time to Sustained Resolution of COVID-19 Symptoms as Measured in the Daily COVID-19 Symptom Diary [ Time Frame: Through Day 29 ]Time to sustained resolution of COVID-19 symptoms through Day 29: Defined as time from the dose date to the first date when all of the defined symptoms are scored as absent with no symptom recurrence or new symptoms, except cough, fatigue, and headache which may be mild or absent, through Day 29.
- Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL) to Day 7 (±1) [ Time Frame: Day 7 (±1) ]Assessed by RT qPCR From NP (Nasopharyngeal) Samples
- Duration of SARS-CoV-2 Shedding Assessed by RT-qPCR From Saliva Samples [ Time Frame: Through Day 29 ]Duration of SARS-CoV-2 viral shedding is defined as time from the dose date to the first date the viral load is not detected, ie, below the limit of detection (LOD), and sustained through Day 29. Participants who do not have the defined event or who discontinue study prior to Day 29 are censored at the earlier date of the last viral load assessment or Day 30. Deaths occurring prior to Day 29 were censored at Day 30.
- Viral Load >5 (log10 Copies/mL) Based on Nasopharyngeal Sampling at Day 7 [ Time Frame: on Day 7 (+/- 1 Day) ]Proportion of participants with Viral load >5 (log10 copies/mL) on Day 7 assessed by RT-qPCR from NP sample.
- SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7) [ Time Frame: Days 5, 7, 11, 14, 21, and 29 (saliva) ]Proportions of SARS-CoV-2 viral clearance (Days 3, 5, 7, 11, 14, 21, and 29) assessed by RT-qPCR from saliva samples: In the mFAS-S, the cumulative proportion of participants with viral clearance (viral load not detected and sustained through Day 29) at Days 3, 5, 7, 11, 14, 21, and 29 will be assessed by RT-qPCR from saliva samples. Participants who have died or discontinued study prior to Day 29 are assumed to have no viral clearance.
- SARS-CoV-2 Viral Load AUC Assessed by RT-qPCR From Saliva Samples [ Time Frame: Baseline to Day 29 ]The AUC from Day 1 through Day 29 was calculated according to the linear trapezoidal rule using the measured SARS-CoV-2 viral load above the lower limit of quantification. No AUC values will be calculated when Day 1 and/or Day 29 values are missing, or if there are more than 3 values missing in the profile.
- Incidence of Treatment Emergent Adverse Events [ Time Frame: 14 months ]An AE is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to the study drug. AEs occurring from when the participant signed the ICF until the Month 14 (EOS) visit or discontinuation from study was recorded
- Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan) [ Time Frame: 14 Months ]A PCS value is defined as any DAIDS grade 4 post-baseline or any increase of 2 or more DAIDS grades post-baseline, except for PCS low creatinine clearance, which is defined as any DAIDS Grade 4 post-baseline or any DAIDS grade shift from 0 to 3. Laboratory parameters not graded by DAIDs will be defined as PCS based on the criteria in the SAP (Appendix K.)
- Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan) [ Time Frame: 14 Months ]
- Incidence of ADA to ADG20 [ Time Frame: 11 months ]
- Genotypic Characterization of Viral Isolates for Reduced Susceptibility to ADG20 (G504 Mutations) [ Time Frame: Through Day 29 ]Post-baseline Treatment-emergent Variations at Amino Acid Positions Associated with Reduced Susceptibility to ADG20 (>/= 15% Allele frequency); data limited to mutations observed.
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
- Has had symptoms consistent with COVID-19 with onset 5 days before randomization
- Has one or more COVID-19-related signs or symptoms on the day of randomization
- Phase 2: Is an adult aged 18 years and above
- Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening
Exclusion Criteria:
- Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.
- Has severe COVID-19 or is on supplemental oxygen
- Has a history of a positive SARS-CoV-2 antibody serology test
- Has participated, within the last 30 days, in a clinical study involving an investigational intervention
- Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study
NOTE: Other protocol defined inclusion/exclusion criteria apply
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): NCT04805671
Locations
Show 68 study locations
Sponsors and Collaborators
Invivyd, Inc.
Study Documents (Full-Text)
Documents provided by Invivyd, Inc.:
Documents provided by Invivyd, Inc.:
Study Protocol [PDF] March 2, 2022
Statistical Analysis Plan [PDF] March 3, 2022
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Invivyd, Inc. |
| ClinicalTrials.gov Identifier: | NCT04805671 |
| Other Study ID Numbers: |
ADG20-TRMT-001 |
| First Posted: | March 18, 2021 Key Record Dates |
| Results First Posted: | February 6, 2024 |
| Last Update Posted: | February 6, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |