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Complement Inhibitor

Danicopan for 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
Awards & highlights

Study Summary

This study is evaluating whether a drug called danicopan can help people with COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 3, 5, 8, 11, 15, 22, 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 5, 8, 11, 15, 22, 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
Secondary outcome measures
14-day Participant Mortality
28-day Participant Mortality
59-day Participant Mortality
+38 more

Side effects data

From 2024 Phase 3 trial • 86 Patients • NCT04469465
11%
Headache
9%
Nausea
7%
Diarrhoea
7%
Arthralgia
5%
Pain in extremity
5%
Alanine aminotransferase increased
5%
Hypertension
5%
Vomiting
5%
Pyrexia
4%
White blood cell count decreased
4%
Myalgia
4%
Aspartate aminotransferase increased
4%
Constipation
4%
Urinary tract infection
4%
Viral infection
4%
Oropharyngeal pain
4%
Rhinorrhoea
4%
Haemolysis
2%
Noninfective gingivitis
2%
Post procedural diarrhoea
2%
Splenomegaly
2%
Upper respiratory tract infection
2%
Flatulence
2%
Hypercholesterolaemia
2%
Chromaturia
2%
Neutropenia
2%
Pancreatitis
2%
Neutrophil count decreased
2%
Oedema peripheral
2%
Hepatic function abnormal
2%
Sinusitis
2%
Flushing
2%
Platelet count decreased
2%
Decreased appetite
2%
Liver disorder
2%
Hot flush
2%
Cholecystitis
2%
Leukopenia
2%
Anaemia
2%
Dry eye
2%
Abdominal pain upper
2%
Dyspepsia
2%
Stomatitis
2%
Jaundice
2%
Localised infection
2%
Cellulitis
2%
Contusion
2%
Blood bilirubin increased
2%
Blood pressure increased
2%
Bone pain
2%
Osteoarthritis
2%
Acne
2%
Rash maculo-papular
2%
Discoloured vomit
2%
Blood lactate dehydrogenase increased
2%
Lymphocyte count decreased
2%
SARS-CoV-2 test positive
2%
Chest discomfort
2%
Hepatic enzyme increased
2%
Fatigue
2%
COVID-19
2%
Proteinuria
2%
Cough
2%
Abdominal discomfort
2%
Fall
2%
Febrile nonhaemolytic transfusion reaction
2%
Post procedural contusion
2%
Post procedural haemorrhage
2%
Skin abrasion
2%
Thoracic vertebral fracture
2%
Dizziness
2%
Lethargy
2%
Hallucination
2%
Insomnia
2%
Epistaxis
2%
Sinus pain
2%
Salivary gland pain
2%
Peripheral swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Danicopan
Placebo

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
3,268 Previous Clinical Trials
5,480,931 Total Patients Enrolled
78 Trials studying COVID-19
292,007 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19
2021. "ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04988035.
~55 spots leftby Apr 2025
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