Trial Outcomes & Findings for PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) (NCT NCT05780541)
NCT ID: NCT05780541
Last Updated: 2024-02-09
Results Overview
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
Through Day 90
Results posted on
2024-02-09
Participant Flow
Subjects were enrolled from 40 sites in 2 countries (Denmark, USA). The first subject was enrolled on 15 Sep 2021 and the last subject was enrolled on 29 Dec 2021.
Of 58 subjects enrolled, 58 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
PF-07304814 Plus SOC
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
26
|
|
Overall Study
COMPLETED
|
32
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Baseline characteristics by cohort
| Measure |
PF-07304814 Plus SOC
n=32 Participants
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Only ethnicity reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through Day 90Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Outcome measures
| Measure |
PF-07304814 Plus SOC
n=32 Participants
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With Sustained Recovery
|
23 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Status on Day 5Ordinal outcome with 7 mutually exclusive categories
Outcome measures
| Measure |
PF-07304814 Plus SOC
n=32 Participants
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With an Ordinal Outcome on Day 5
7 = Death
|
0 Participants
|
4 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy
|
5 Participants
|
3 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
5 = Non-invasive ventilation or high flow oxygen
|
11 Participants
|
5 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
4 = Supplement oxygen (≥4 L/min or ≥4 L/min above baseline, but not high flow oxygen)
|
5 Participants
|
5 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
3 = Supplement oxygen (<4 L/min or <4 L/min above baseline, but not high flow oxygen)
|
5 Participants
|
0 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
2 = Limiting symptoms due to COVID-19, but no need of new or increased oxygen from baseline
|
3 Participants
|
4 Participants
|
|
Number of Participants With an Ordinal Outcome on Day 5
1 = No limiting symptoms due to COVID-19
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Through Day 90All-cause mortality
Outcome measures
| Measure |
PF-07304814 Plus SOC
n=32 Participants
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants Who Died From All Causes
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Through Day 5Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5
Outcome measures
| Measure |
PF-07304814 Plus SOC
n=32 Participants
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With a Safety Outcome Through Day 5
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28
Outcome measures
| Measure |
PF-07304814 Plus SOC
n=32 Participants
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With a Safety Outcome Through Day 28
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through Day 90Death, SAE, clinical organ failure, serious infections through Day 90
Outcome measures
| Measure |
PF-07304814 Plus SOC
n=32 Participants
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 Participants
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Number of Participants With a Safety Outcome Through Day 90
|
15 Participants
|
11 Participants
|
Adverse Events
PF-07304814 Plus SOC
Serious events: 2 serious events
Other events: 11 other events
Deaths: 9 deaths
Placebo Plus SOC
Serious events: 1 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
PF-07304814 Plus SOC
n=32 participants at risk
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 participants at risk
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/32 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Deep vein thrombosis
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
Other adverse events
| Measure |
PF-07304814 Plus SOC
n=32 participants at risk
* PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
PF-07304814: PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Remdesivir: Antiviral agent
|
Placebo Plus SOC
n=26 participants at risk
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo: Commercially available 0.9% sodium chloride solution
Remdesivir: Antiviral agent
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/32 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Cardiac disorders
Bradycardia
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Enteritis
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
3.1%
1/32 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Intestinal perforation
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
General disorders
Oedema
|
0.00%
0/32 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Pneumonia klebsiella
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Sepsis
|
6.2%
2/32 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Infections and infestations
Pneumonia bacterial
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Renal and urinary disorders
Hematuria
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
11.5%
3/26 • Number of events 3 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
2/32 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
7.7%
2/26 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.4%
3/32 • Number of events 3 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/32 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
7.7%
2/26 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
3.8%
1/26 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
7.7%
2/26 • Number of events 2 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Labile blood pressure
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
|
Vascular disorders
Shock
|
3.1%
1/32 • Number of events 1 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
0.00%
0/26 • 90 Days
Only Grade 3 or 4 AEs were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place