Clinical trial: ACTIV-2: A Study for Outpatients With COVID-19 (NCT04518410)

Eligibility criteria:
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 and conducted an any US clinic or laboratory that has a
             Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or
             any non-US DAIDS-approved laboratory.

          -  Able to begin study treatment no later than 8 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:

               -  fever or feeling feverish

               -  cough

               -  shortness of breath or difficulty breathing at rest or when active

               -  sore throat

               -  body pain or muscle pain/aches

               -  fatigue

               -  headache

               -  chills

               -  blocked nose/nasal congestion

               -  runny nose

               -  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:

               -  fever or feeling feverish

               -  cough

               -  shortness of breath or difficulty breathing at rest or when active

               -  sore throat

               -  body pain or muscle pain/aches

               -  fatigue

               -  headache

               -  chills

               -  blocked nose/nasal congestion

               -  runny nose

               -  loss of taste or smell

               -  nausea or vomiting

               -  diarrhea

               -  temperature ≥ 38°C (100.4°F)

          -  Oxygen levels of ≥92% when resting (measured by study staff within 24 hours of
             participating in the study). 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 severe
             COVID-19 (BRII-196/BRII-198, AZD7442 [IV]).

          -  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, CL135-LS+C144-LS).

          -  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 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 (C135-LS+C144-LS).

        Exclusion Criteria:

          -  History of or current hospitalization for COVID-19.

          -  For the current SARS-CoV-2 infection, any positive SARS-CoV-2 molecular test from any
             respiratory tract specimen collected more than 10 days prior to study entry.

          -  Current need for hospitalization or immediate medical attention.

          -  Any use of the following medications up to 30 days before participating in the study:

               -  Hydroxychloroquine (except for long-term autoimmune diseases)

               -  Chloroquine and/or ivermectin (unless used for parasitic infection)

               -  Remdesivir, systemic and inhaled steroids (unless used for long-term conditions)

               -  HIV protease inhibitors (unless used long-term for HIV infection)

          -  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).

          -  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, C135-LS+C144-LS).

          -  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
             (C135-LS+C144-LS).

          -  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).

          -  Meet the protocol definition of being at "higher" risk of progression to sever
             COVID-19 (C135-LS+C144-LS).

        Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment