Human COVID-19 Immunoglobulin (COVID-HIG) Therapy for COVID-19 Patients

NCT ID: NCT05173441

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2023-11-30

Brief Summary

A randomized, double-blind, placebo-controlled phase II exploratory clinical trial to evaluate the efficacy and safety of Human COVID-19 immunoglobulin (pH4) for intravenous injection (COVID-HIG) in the treatment of patients with COVID-19.

Detailed Description

Eligible adault patients with confirmed COVID-19 will be randomized 1:1:1 to receive intravenous injections of High-dose COVID-HIG, Low-dose COVID-HIG or Placebo ( 0.9% sodium chloride injection). Patients in each arm will receive continued standard of care (SOC) therapy. The primary efficacy end point is the median time to clinical improvement (defined as clinical improvement of at least 2 points from baseline on the 7-point ordinal scale) observed from 0 to 28 days after the first administration.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High Dose Group

Standard of care (SOC)+high dose COVID-HIG. COVID-HIG will be administered via intravenous infusion. once a day, for three consecutive days (Day 0, day 1, and Day 2). And it could be administered again for 1-2 days according to the clinical improvement of subjects, and the total number of infusions should not exceed5 times.

Group Type: EXPERIMENTAL

Human COVID-19 immunoglobulin (pH4) for intravenous injection

Intervention Type: BIOLOGICAL

The initial infusion rate is 0.01 \~ 0.02 ml/kg body weight/minute (1ml is about 20 drops). If there was no adverse reaction after 15 minutes, the infusion rate could be gradually accelerated. However, it should not exceed 0.08 ml/kg body weight/minute.

Low Dose Group

Standard of care (SOC)+low dose COVID-HIG. COVID-HIG will be administered via intravenous infusion. once a day, for three consecutive days (Day 0, day 1, and Day 2). And it could be administered again for 1-2 days according to the clinical improvement of subjects, and the total number of infusions should not exceed5 times.

Group Type: EXPERIMENTAL

Human COVID-19 immunoglobulin (pH4) for intravenous injection

Intervention Type: BIOLOGICAL

The initial infusion rate is 0.01 \~ 0.02 ml/kg body weight/minute (1ml is about 20 drops). If there was no adverse reaction after 15 minutes, the infusion rate could be gradually accelerated. However, it should not exceed 0.08 ml/kg body weight/minute.

Control Group

Standard of care (SOC)+placebo (0.9% sodium chloride). Placebo will be administered via intravenous infusion. once a day, for three consecutive days (Day 0, day 1, and Day 2). And it could be administered again for 1-2 days according to the clinical improvement of subjects, and the total number of infusions should not exceed5 times.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The initial infusion rate is 0.01 \~ 0.02 ml/kg body weight/minute (1ml is about 20 drops). If there was no adverse reaction after 15 minutes, the infusion rate could be gradually accelerated. However, it should not exceed 0.08 ml/kg body weight/minute

Interventions

Human COVID-19 immunoglobulin (pH4) for intravenous injection

The initial infusion rate is 0.01 \~ 0.02 ml/kg body weight/minute (1ml is about 20 drops). If there was no adverse reaction after 15 minutes, the infusion rate could be gradually accelerated. However, it should not exceed 0.08 ml/kg body weight/minute.

Intervention Type: BIOLOGICAL

Placebo

The initial infusion rate is 0.01 \~ 0.02 ml/kg body weight/minute (1ml is about 20 drops). If there was no adverse reaction after 15 minutes, the infusion rate could be gradually accelerated. However, it should not exceed 0.08 ml/kg body weight/minute

Intervention Type: DRUG

Other Intervention Names

COVID-HIG; 0.9% sodium chloride injection

Eligibility Criteria

Inclusion Criteria

1. ≥18 and <65 years of age when signing the ICF, male or femal.

2. Positive testing by virologic test (SARS-CoV-2 virus nucleic acid test,result of RT-PCR within 3 days are accpetable) before randomization.

3. COVID-19 related clinical symptoms (fever or respiratory symptoms, etc.) progresses before randomization.

4. Inpatients with moderate or severe COVID-19 (severity is graded by FDA standard).

5. With early warning signs for severe/critical cases, meet any of the following indicators: ①Progressive exacerbation of hypoxemia or respiratory distress; ②Deterioration of tissue oxygenation or progressive hyperlactatemia. ③ Rapid decrease in lymphocyte count or steady increase in inflammatory markers such as IL-6, CRP, and ferritin. ④Significant increase of D-dimer and other related indexes of coagulation function. ⑤Chest imaging showing rapid progression of lung lesions.

6. Randomization should be within 10 days of COVID-19 symptoms onset.

7. Subjects (including their partners) have no pregnancy plan and voluntarily take effective contraceptive measures from signing ICF to 3 months after he/she finished the trial.

8. Willing to comply with the requirements, and cooperate when collecting of nasopharyngeal swabs and venous blood for testing according to the protocol; and willing to complete the study.

9. Able to consent, and willing to sign the ICF.

Exclusion Criteria

1. Asymptomatic infection, mild or critical COVID-19.

2. SP02 < 93% under high-flow oxygen inhalation, or receiving of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

3. Reinfected subjects with historical confirmed COVID-19, detectable by SARS-CoV-2 serological test (nasopharyngeal SARS-CoV-2 RNA levels or serum antibody).

4. May be transferred to another hospital, that is not one of the trial sites, within 72 hours.

5. Meets one of the following high-risk factors: a) Pre-existing cardiovascular (including uncontrolled hypertension: SBP≥ 160 mmHg and/or DBP≥ 100 mmHg) and cerebrovascular diseases, chronic lung diseases (chronic obstructive pulmonary disease (COPD), moderate to severe asthma), diabetes (HbA1c > 9.0%), chronic liver diseases, chronic kidney diseases, malignancies or other complicated diseases. b) Pre-existing Immunosuppression (such as AIDS, long-term use of corticosteroids or other immunosuppressive drugs that lead to a weakened immune function). c) Obesity: body mass index ≥ 35. d) Heavy smokers: ≥20 cigarettes per day on average.

6. History of allergic to IVIG, other plasma proteins or blood products, history of selective IgA deficiency with presence of anti-IgA antibodies.

7. Vaccinated in last 8 weeks, such as influenza, poliomyelitis, measles, rubella, mumps and varicella virus vaccines.

8. May worsen and progress to critical COVID-19 rapidly.

9. Useage of other antiviral drugs to treat SARS-CoV-2 (except the basic treatment specified in the protocol) before randomization.

10. History of major surgery (defined as life-threatening surgery, requiring general anesthesia and causing severe bleeding, including bone and joint surgery on elbow, shoulder, hip, knee, ankle and spine) within 8 weeks before screening (including 8 weeks), or plan to surgery during the trial, which may bring unacceptable risks to the subjects, evaluation by investigators.

11. ALT or AST > 2 times of the normal range upper limit, or Ccr < 60 ml/min.

12. D-dimer increased significantly (> 1 mg/L); History of thromboembolism or coagulation diseases in last 1 year, such as acute coronary syndrome, cerebrovascular syndrome, pulmonary or deep vein thrombosis, etc.

13. Positive of virues makers ( positive of HBsAg, HCV-Ab, or Treponema pallidum specific antibody).

14. History of organ transplantation (such as heart, lung, liver, kidney, etc.

15. Pregnant or lactating female.

16. Other subjects who are not suitable to participate in the trial considered by the investigator, such as potential compliance problems, can not complete all the examinations and evaluations according to the protocol, mental illness, obvious mental disorders; Incapacity or cognitive ability caused by other reasons.

17. History of participated in other investigate drugs or medical devices clinical trials in last 1 month before signing ICF.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role: collaborator

Beijing Tiantan Biological Products Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nawal Al Kaabi, MBBA

Role: PRINCIPAL_INVESTIGATOR

Sheikh Khalifa Medical City, SEHA

Locations

Al Rahba Hospital

Abu Dhabi, , United Arab Emirates

Countries

United Arab Emirates

Central Contacts

YunKai Yang, Prof

Role: CONTACT

yangyunkai@sinopharm.com

+86-13601126881

Facility Contacts

Nawal AI Kaabi, MBBA

Role: primary

nalkaabi@seha.ae

+971505595521

Other Identifiers

COVID-19-IVIG-201

Identifier Type: -

Identifier Source: org_study_id