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Complement Inhibitor
ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 3, 5, 8, 11, 15, 22, 29
Summary
This trial is testing whether adding a new drug, danicopan, to an existing treatment, remdesivir, can improve outcomes for hospitalized adults with COVID-19. Remdesivir helps reduce virus levels, and danicopan may enhance this effect. Remdesivir is an antiviral drug that has been shown to reduce recovery time in hospitalized COVID-19 patients and is approved by the FDA for treating both hospitalized and nonhospitalized COVID-19 patients.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 3, 5, 8, 11, 15, 22, 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 3, 5, 8, 11, 15, 22, 29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
Secondary study objectives
14-day Participant Mortality
28-day Participant Mortality
59-day Participant Mortality
+38 moreSide effects data
From 2024 Phase 3 trial • 88 Patients • NCT0446946513%
Pyrexia
11%
Diarrhoea
11%
Headache
5%
Fatigue
5%
Neutropenia
5%
Anaemia
4%
Asthenia
4%
Dyspnoea
4%
Back pain
4%
Dizziness
4%
Breakthrough haemolysis
4%
Gastroenteritis
2%
Urinary tract infection
2%
COVID-19
2%
Chromaturia
2%
Thrombocytopenia
2%
Nausea
2%
Pain in extremity
2%
Aspartate aminotransferase increased
2%
Vomiting
2%
COVID-19 pneumonia
2%
Cough
2%
Staphylococcal sepsis
2%
Contusion
2%
Chest discomfort
2%
Constipation
2%
Abdominal pain
2%
Insomnia
2%
Dieulafoy's vascular malformation
2%
Arthralgia
2%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Danicopan-Danicopan (TP2)
Placebo-Danicopan (TP2)
Danicopan-Danicopan (LTE)
Placebo-Danicopan (LTE)
Danicopan (TP1)
Placebo (TP1)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Remdesivir + Danicopan (>/= 70 years)Experimental Treatment2 Interventions
For participants \>/= 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 300 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 200 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 200 mg 3 times daily (TID) for 2 days, followed by 200 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan participants, N=100.
Group II: Remdesivir + Danicopan (< 70 years)Experimental Treatment2 Interventions
For participants \< 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg 3 times daily (TID) for 2 days, followed by 250 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan participants, N=100.
Group III: Remdesivir + Placebo (< 70 years)Active Control2 Interventions
For participants \< 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg 3 times daily (TID) for 2 days, followed by 250 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan matching placebo participants, N=100.
Group IV: Remdesivir + Placebo (>/= 70 years)Active Control2 Interventions
For participants \>/= 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 300 mg oral (PO) (or via nasogastric \[NG\] or gastrostomy \[G\] tube) of loading dose danicopan matching placebo followed by 200 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 200 mg 3 times daily (TID) for 2 days, followed by 200 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan matching placebo participants, N=100.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danicopan
2020
Completed Phase 3
~680
Remdesivir
2020
Completed Phase 3
~21440
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,392,563 Total Patients Enrolled