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ACTIV-2: A Study for Outpatients With COVID-19
Recruiting
I'm InterestedTrial ID: NCT04518410
Purpose
Drug studies often look at the effect one or two drugs have on a medical condition, and
involve one company. There is currently an urgent need for one study to efficiently test
multiple drugs from more than one company, in people who have tested positive for COVID-19
but who do not currently need hospitalization. This could help prevent disease progression to
more serious symptoms and complications, and spread of COVID-19 in the community.
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in
outpatients. In Phase II, participants in the study will be treated with either a study drug
or with placebo. In protocol version 7.0, participants in Phase III of the study will be
treated with either a study drug or active comparator drug. Participants assigned to the
bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study
drug administration, followed by limited follow-up through 24 weeks in phase II and in phase
III. All other investigational agents and their corresponding placebo arms will involve 28
days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and
phase III. Additional study visits may be required, depending on the agent.
Official Title
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Stanford Investigator(s)
Upinder Singh
Stanford Medicine Professor of Infectious Disease and Professor of Medicine (Infectious Diseases & Geographic Medicine) and of Microbiology and Immunology
Eligibility
Inclusion Criteria:
- Signed informed consent.
- Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a
molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g.
oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10
days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US
must be conducted at a DAIDS-approved laboratory.
- Able to begin study treatment no later than 7 days from self-reported onset of
COVID-19 related symptom(s) or measured fever, where the first day of symptoms is
considered symptom day 0 and defined by the self-reported date of first reported
sign/symptom from the following list:
- subjective fever or feeling feverish
- cough
- shortness of breath or difficulty breathing at rest or with activity
- sore throat
- body pain or muscle pain/aches
- fatigue
- headache
- chills
- nasal obstruction or congestion
- nasal discharge
- loss of taste or smell
- nausea or vomiting
- diarrhea
- temperature > 38°C (100.4°F)
- One or more of the following signs/symptoms within 24 hours of participating in the
study:
- subjective fever or feeling feverish
- cough
- shortness of breath or difficulty breathing at rest or with activity
- sore throat
- body pain or muscle pain/aches
- fatigue
- headache
- chills
- nasal obstruction or congestion
- nasal discharge
- loss of taste or smell
- nausea or vomiting
- diarrhea
- temperature > 38°C (100.4°F)
- Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study
staff within 24 hours of study entry. For a potential participant who regularly
receives chronic supplementary oxygen for an underlying lung condition, their oxygen
saturation should be measured while on their standard home oxygen supplementation
level.
- Participant must agree not to participate in another clinical trial for the treatment
of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days
after the start of the study, whichever occurs first.
- Meet the protocol definition of being at "higher" risk of progression to
hospitalization or death (BRII-196/BRII-198).
- In Phase III, meeting the protocol definition of being at "higher" risk of progression
to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
- For participants of reproductive potential, negative serum or urine pregnancy test
within 48 hours prior to study entry by any clinic or laboratory that has a CLIA
certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note:
Participants not of reproductive potential are eligible without requiring the use of a
contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat,
SAB-185, BMS 986414+BMS 986413).
- Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives. They are
strongly advised to inform their non-pregnant sexual partners of reproductive
potential to use effective contraceptives for 24 weeks after investigational product
is administered. Participants with pregnant partners should use condoms during vaginal
intercourse through 24 weeks after investigational agent administration. Participants
should refrain from sperm donation for 24 weeks after investigational agent
administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
- Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives for 30 days
after investigational agent administration. They are also strongly advised to inform
their non-pregnant sexual partners of reproductive potential to sue effective
contraceptives for 30 days after investigational agent is administered to the
participant. Participants with pregnant partners should use condoms during vaginal
intercourse through 30 days after last dose of investigational agent administration.
Participants should refrain from sperm donation for 30 days after investigational
agent administration (SNG001).
- Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives. They are
also strongly advised to inform their non-regnant sexual partners of reproductive
potential to use effective contraceptives from study entry through 90 days after study
treatment. Participants with pregnant partners should use condoms during vaginal
intercourse from study entry through 90 days after the last dose of the study
treatment. Participants should refrain from sperm donation from study entry through 90
days after the last dose of study treatment (Camostat).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 24 weeks after
investigational agent is administered. This would include oral contraceptives,
implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier
methods.
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use highly effective contraception for 24
weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM],
SAB-185).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 30 days after
investigational agent is administered (SNG001).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 90 days after
the last dose of treatment (Camostat).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use highly effective contraception for at
least 48 weeks after the investigational agent is administered (BMS 986414+BMS
986413).
Exclusion Criteria:
- History of or current hospitalization for COVID-19.
- For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen
tests from any respiratory tract specimen collected > 240 hours prior to study entry.
- Current need for hospitalization or immediate medical attention.
- Use of any prohibited medication listed in the protocol and/or use of systemic or
inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from
chronic baseline) within 30 days prior to study.
- Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2
treatment or prophylaxis at any time prior to study entry.
- Receipt of other investigational treatments for SARS-CoV-2 any time before
participating in the study (not including drugs approved and taken for other
conditions/diseases or COVID-19 vaccines).
- Known allergy/sensitivity or hypersensitivity to study drug or placebo.
- Any condition requiring surgery up to 7 days before participating in the study, or
that is considered life threatening up to 30 days before participating in the study.
- Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM],
SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
- In phase II, meeting the protocol definition of being at "higher" risk of progression
to hospitalization or death (AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185,
BMS 986414+BMS 986413).
- Inflammatory skin conditions that compromise the safety of intramuscular (IM)
injections, or other overlying skin conditions or tattoos that would preclude the
assessment of injection site reactions, per the discretion of the investigator
(AZD7442 [IM]).
- Inflammatory skin conditions that compromise the safety of subcutaneous (SC)
injections, or other overlying skin conditions or tattoos that would preclude the
assessment of infection site reactions, per the discretion of the investigator (BMS
986414+BMS 986413).
- History of coagulopathy which, in the opinion of the investigator, would preclude IM
injection, or use of oral or injectable anticoagulants (protocol provides more
information on prohibited medications) (AZD7442 [IM]).
- Use of or need for chronic supplemental oxygen (SNG001).
- Known severe liver disease prior to enrollment (defined as ALT or AST > 5 times upper
limit of normal or end stage liver disease with Child-Pugh Class C or
Child-Pugh-Turcotte score ≥ 10) (Camostat).
- Known severe kidney disease prior to enrollment (defined as estimated glomerular
filtration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such as
peritoneal dialysis or hemodialysis (Camostat)
Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
Intervention(s):
biological: AZD7442 (IV)
biological: AZD7442 (IM)
drug: SNG001
drug: Camostat
biological: SAB-185 (3,840 Units/kg)
biological: SAB-185 (10,240 Units/kg)
biological: BMS-986414 + BMS-986413
drug: CASIRIVIMAB + IMDEVIMAB
biological: bamlanivimab 7000mg
biological: BRII-196+BRII-198
drug: Placebo for Bamlanivimab 7000mg
drug: Placebo for Bamlanivimab 700mg
drug: Placebo for BRII-196+BRII-198
drug: Placebo for SNG001
drug: Placebo for Camostat
drug: Placebo for SAB-185 (low dose)
drug: Placebo for BMS-986414 + BMS-986413
drug: Placebo for AZD7442 (IV)
drug: Placebo for AZD7442 (IM)
drug: Placebo for SAB-185 (high dose)
biological: bamlanivimab 700mg
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Julia Donahue
650-725-3515