Trial Outcomes & Findings for MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) (NCT NCT05780463)

Last Updated: 2024-02-05

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

COMPLETED

Study phase

PHASE3

Target enrollment

485 participants

Primary outcome timeframe

Through Day 90

Results posted on

2024-02-05

Participant Flow

Subjects were enrolled from 62 sites in 10 countries (Denmark, Greece, Nigeria, Poland, Singapore, Spain, Switzerland, Uganda, UK, USA). The first subject was enrolled on 11 Jun 2021 and the last subject was enrolled on 15 Nov 2021.

Participant milestones

Participant milestones
Measure	MP0420 Plus SOC * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. 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	247	238
Overall Study COMPLETED	247	238
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MP0420 Plus SOC n=247 Participants * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=238 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=485 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 14.9 • n=5 Participants	56.6 years STANDARD_DEVIATION 16.6 • n=7 Participants	56.7 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	110 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants	128 Participants n=7 Participants	275 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	206 Participants n=5 Participants	200 Participants n=7 Participants	406 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 Asian	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	138 Participants n=5 Participants	128 Participants n=7 Participants	266 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Only ethnicity reported	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Day 90

Sustained 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

Outcome measures
Measure	MP0420 Plus SOC n=247 Participants * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=238 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	203 Participants	190 Participants

PRIMARY outcome

Timeframe: Status on Day 5

Ordinal outcome with 7 mutually exclusive categories

Outcome measures

Outcome measures
Measure	MP0420 Plus SOC n=242 Participants * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=233 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	1 Participants	3 Participants
Number of Participants With an Ordinal Outcome on Day 5 6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy	16 Participants	10 Participants
Number of Participants With an Ordinal Outcome on Day 5 5 = Non-invasive ventilation or high flow oxygen	46 Participants	45 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)	40 Participants	30 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)	36 Participants	45 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	58 Participants	49 Participants
Number of Participants With an Ordinal Outcome on Day 5 1 = No limiting symptoms due to COVID-19	45 Participants	51 Participants

SECONDARY outcome

Timeframe: Through Day 90

All-cause mortality

Outcome measures

Outcome measures
Measure	MP0420 Plus SOC n=247 Participants * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=238 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	30 Participants	35 Participants

SECONDARY outcome

Timeframe: Through Day 5

Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5

Outcome measures

Outcome measures
Measure	MP0420 Plus SOC n=247 Participants * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=238 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	61 Participants	70 Participants

SECONDARY outcome

Timeframe: Through Day 28

Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28

Outcome measures

Outcome measures
Measure	MP0420 Plus SOC n=247 Participants * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=238 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	85 Participants	97 Participants

SECONDARY outcome

Timeframe: Through Day 90

Death, SAE, clinical organ failure, serious infections through Day 90

Outcome measures

Outcome measures
Measure	MP0420 Plus SOC n=247 Participants * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=238 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	78 Participants	70 Participants

Adverse Events

MP0420 Plus SOC

Serious events: 14 serious events

Other events: 65 other events

Deaths: 30 deaths

Placebo Plus SOC

Serious events: 18 serious events

Other events: 79 other events

Deaths: 35 deaths

Serious adverse events

Other adverse events

Additional Information

Greg Grandits

University of Minnesota

Phone: 651-528-9491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MP0420 Plus SOC n=247 participants at risk * MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	Placebo Plus SOC n=238 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 Anaemia	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Cardiac disorders Atrial fibrillation	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Hemorrhoids	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Pancreatitis	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Abdominal wall hematoma	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
General disorders Injection site haematoma	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
General disorders Pyrexia	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Hepatobiliary disorders Gallbladder polyp	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Hepatobiliary disorders Hypertransaminasemia	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Chilblains	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Injury, poisoning and procedural complications Thermal burn	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkins's disease	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Nervous system disorders Toxic encephalopathy	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Psychiatric disorders Confusion state	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Renal and urinary disorders Acute kidney injury	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.84% 2/238 • Number of events 2 • 90 Days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Surgical and medical procedures Toe amputation	0.40% 1/247 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.	0.00% 0/238 • 90 Days Only Grade 3 or 4 AEs were collected.
Vascular disorders Hypertension	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.42% 1/238 • Number of events 1 • 90 Days Only Grade 3 or 4 AEs were collected.
Vascular disorders Deep vein thrombosis	0.00% 0/247 • 90 Days Only Grade 3 or 4 AEs were collected.	0.84% 2/238 • Number of events 2 • 90 Days Only Grade 3 or 4 AEs were collected.