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New treatment option for Covid19
Official title AGILE (Early Phase Platform Trial for COVID-19)
ClinicalTrials.gov ID: NCT04746183
What this study is testing
What is CST-2: EIDD-2801?
CST-2: EIDD-2801 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for covid19.
Also referred to as MK-4482, Molnupiravir.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The AGILE platform master protocol allows incorporation of a range of identified and yet-to-be-identified candidates as potential treatments for adults with COVID-19 into the trial. Candidates will be added into the trial via candidate-specific trial (CST) protocols of this master protocol as appendices.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Master Protocol
- Adults (≥18 years) with laboratory-confirmed\ SARS-CoV-2 infection (PCR)
- Ability to provide informed consent signed by study patient or legally acceptable representative
- Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of...
- If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also...
You likely can't join if
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5 times the upper limit of normal (ULN)
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate \<30 mL/min/1.73 m\^2)
- Pregnant or breast feeding
- Anticipated transfer to another hospital which is not a study site within 72 hours
- Allergy to any study medication
- Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment
See the full eligibility criteria
Who can join
- Master Protocol
- Adults (≥18 years) with laboratory-confirmed\ SARS-CoV-2 infection (PCR)
- Ability to provide informed consent signed by study patient or legally acceptable representative
- Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in the protocol) from the first administration of...
- If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible. Standard additional criteria that may be applied per CST protocol...
- Group A (severe disease). Patients with clinical status of Grades 5 (hospitalised, oxygen by mask or nasal prongs), 6 (hospitalised, on non-invasive ventilation, or high flow oxygen as defined by the WHO Clinical...
- Less than or equal to 14 days from onset of COVID-19 symptoms CST-8
- For the purpose of CST-8, criteria 1 has been amended from the Master Protocol to: Adults (≥18 years) outpatients positive lateral flow test at screening or baseline Day 1, who are within 5 days of symptom onset prior...
- Criteria 3 has been amended from the Master Protocol to: Women of childbearing potential (WOCBP) and male participants who are sexually active with WOCBP must agree to use a highly effective method of contraception (as...
- Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomisation and at least 1 of the current specified COVID-19 signs/symptoms (listed on the NHS website) present on the day of randomisation
- Is willing and able to comply with all study procedures and attending clinic visits CST-9a For the purpose of CST-9a, criteria 1 has been amended from the Master Protocol to:
- Adults (\>/= 18 years of age) with a positive SARS-CoV-2 lateral flow test on screening or Day 1, who are at high risk (as defined in UK DHSC criteria) of progressing to severe COVID-19 disease, within 3 days of symptom...
- Ability to provide informed consent signed by trial participant or legally acceptable representative and are willing and able to comply with all trial procedures and attending clinic visits Criterion 3 has been amended...
- Women of childbearing potential (WOCBP) and male participants who are sexually active with WOCBP must agree to use two effective methods of contraception, one of which must be highly effective for the duration of the...
What rules you out
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5 times the upper limit of normal (ULN)
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate \<30 mL/min/1.73 m\^2)
- Pregnant or breast feeding
- Anticipated transfer to another hospital which is not a study site within 72 hours
- Allergy to any study medication
- Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment
- Patients participating in another CTIMP trial N.B. The CST protocol exclusion criteria will take precedence over the master protocol exclusion criteria. CST-9a Exclusion Criteria: Exclusion criteria has been amended...
- Prior SARS-CoV-2 infection \<90 days before enrolment and/or received any COVID-19 vaccine dose \<90 days before enrolment
- Alanine aminotransferase (ALT) \>3 times the upper limit of normal (ULN) or Active Liver disease
- History or current evidence of cirrhosis
- Receiving dialysis or have known moderate to severe renal impairment (defined as CKD stage 4 or 5) or current acute kidney injury on most recent eGFR in the past 6 months
- Pregnant or breast feeding
- Anticipated transfer to another hospital which is not a trial site within 72 hours
- Known allergy to any trial medication
- Swallowing difficulties
- Currently receiving ALG-097558, Paxlovid, molnupiravir or remdesivir or any SoC therapy for COVID-19 at the time of screening
- Received sotrovimab at any point during the current SARS-CoV-2 infection
- Oxygen saturations \<94% on room air
- Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.
- Participants who have taken or require treatment with a comedication that is a strong CYP450 3A4 inhibitor (atazanavir, clarithromycin, itraconazole, posaconazole, voriconazole, nefazodone, nelfinavir, grapefruit juice...
- Participating in another CTIMP trial CST-9b Exclusion criteria:
- Prior SARS-CoV-2 infection diagnosed \<90 days before enrolment and/or received any COVID-19 vaccine dose \<90 days before enrolment
- Alanine aminotransferase (ALT) \>3 times the upper limit of normal (ULN) or Active Liver disease
- History or current evidence of cirrhosis
- Receiving dialysis or have known severe renal impairment defined as CKD stage 5 (an eGFR \<15 mL/min/1.73 m2 at screening, or current acute kidney injury in most recent eGFR in past 6 months.
- Pregnant or breast feeding
- Anticipated transfer to another hospital which is not a trial site within 72 hours
- Known allergy to any trial medication
- Swallowing difficulties
- Currently receiving ALG-097558, Paxlovid, molnupiravir or remdesivir or any standard of care antiviral therapy for COVID-19 at the time of screening
- Received sotrovimab at any point during the current SARS-CoV-2 infection prior to enrolment
- Oxygen saturations \<94% on room air. NOTE: Participants on stable oxygen therapy, including use of NIPPV (non-invasive positive pressure ventilation), for a pre-existing medical condition (e.g., COPD) may be included...
- Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.
- Participants who have taken or require treatment with a comedication that is a strong CYP450 3A4 inhibitor (atazanavir, clarithromycin, itraconazole, posaconazole, voriconazole, nefazodone, nelfinavir, grapefruit juice...
- Participating in another CTIMP trial within 5 half-lives of the last administered dose of an investigational medicinal product.
- Participants eligible for other antiviral treatment according to DHSC criteria, or those otherwise eligible for CST9a.
The study team makes the final eligibility decision.
Where it's taking place
- Cape Town, South Africa
- Johannesburg, South Africa
- Liverpool, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cape Town, South Africa; Johannesburg, South Africa; Liverpool, United Kingdom; London, United Kingdom; Manchester, United Kingdom; Southampton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.