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Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

Primary Purpose

Confirmed Coronavirus Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ruconest

About this trial

This is an interventional treatment trial for Confirmed Coronavirus Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-85 years,
Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19 infection).
Evidence of pulmonary involvement on CT scan or X-Ray of the chest,
Symptom onset within the previous 10 days AND at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3) obesity (BMI>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein of >35mg/L, 7) oxygen saturation at rest in ambient air of <94%

Exclusion Criteria:

Contraindications to the class of drugs under study (C1 esterase inhibitor);
History or suspicion of allergy to rabbits;
Women who are of childbearing potential and not using methods of contraception during the entire study period;
Pregnant or breastfeeding females or has a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening;
Chronic liver disease (any Child-Pugh score B or C);
Currently admitted to an ICU or expected admission within the next 24 hours; and
Currently receiving invasive or non-invasive ventilation

Sites / Locations

The Valley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ruconest

Standard of Care

Arm Description

Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered.

SOC

Outcomes

Primary Outcome Measures

Disease Severity on the 7-Point WHO Ordinal Scale

The primary endpoint will be the disease severity on the 7-point WHO Ordinal Scale on day 7. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19

Secondary Outcome Measures

Clinical improvement

at least 2 points Ordinal Scale for Clinical Improvement, clinical severity will be assessed.

Invasive or non-invasive ventilation

Admission to ICU with invasive or non-invasive ventilation or death will be assessed.

Acute Lung Injury

Patients with ALI within 14 days after enrollment, PaO2/FiO2 will be determined daily. This is only relevant for patients with arterial blood gas sampling performed in the ICU or rarely in the medical unit.

Full Information

NCT ID

NCT04530136

First Posted

August 26, 2020

Last Updated

June 2, 2022

Sponsor

Pharming Technologies B.V.

1. Study Identification

Unique Protocol Identification Number

NCT04530136

Brief Title

Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

Official Title

Recombinant Human C1 Esterase Inhibitor (Ruconest®) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial in the United States (PROTECT-COVID-19-US)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 30, 2020 (Actual)

Primary Completion Date

September 7, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharming Technologies B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.

Detailed Description

Patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an open-label controlled design to treatment with rhC1-INH in addition to SOC or SOC only starting on day 0. The first rhC1-INH treatment will be administered on the same day and continued for a total of 4 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Confirmed Coronavirus Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ruconest

Arm Type

Experimental

Arm Description

Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered.

Arm Title

Standard of Care

Arm Type

Other

Arm Description

SOC

Intervention Type

Drug

Intervention Name(s)

Ruconest

Other Intervention Name(s)

SOC

Intervention Description

Patients will be randomized to Ruconest or Standard of Care

Primary Outcome Measure Information:

Title

Disease Severity on the 7-Point WHO Ordinal Scale

Description

The primary endpoint will be the disease severity on the 7-point WHO Ordinal Scale on day 7. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19

Time Frame

Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline value

Secondary Outcome Measure Information:

Title

Clinical improvement

Description

at least 2 points Ordinal Scale for Clinical Improvement, clinical severity will be assessed.

Time Frame

Daily until day 14

Title

Invasive or non-invasive ventilation

Description

Admission to ICU with invasive or non-invasive ventilation or death will be assessed.

Time Frame

Daily until day 14.

Title

Acute Lung Injury

Description

Time Frame

Daily until day 14.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-85 years, Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19 infection). Evidence of pulmonary involvement on CT scan or X-Ray of the chest, Symptom onset within the previous 10 days AND at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3) obesity (BMI>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein of >35mg/L, 7) oxygen saturation at rest in ambient air of <94% Exclusion Criteria: Contraindications to the class of drugs under study (C1 esterase inhibitor); History or suspicion of allergy to rabbits; Women who are of childbearing potential and not using methods of contraception during the entire study period; Pregnant or breastfeeding females or has a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening; Chronic liver disease (any Child-Pugh score B or C); Currently admitted to an ICU or expected admission within the next 24 hours; and Currently receiving invasive or non-invasive ventilation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Bernstein, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Valley Hospital

City

Ridgewood

State/Province

New Jersey

ZIP/Postal Code

07450

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

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