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

NCT05173441 | Unknown Phase 2 DMC

• 1 other identifier: COVID-19-IVIG-201
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; immunoglobulin; COVID-HIG; SARS-CoV-2; 2019nCov; hyperimmune globulin; Coronavirus disease 2019; passive immunotherapy; therapeutic

Outcome Measures

Primary Outcomes (1)

• Time to clinical improvement

  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. 1. Death 2. Hospitalized, receiving Invasive mechanical ventilation or ECMO 3. Hospitalized, receiving non-invasive ventilation or high-flow oxygen devices 4. Hospitalized, requiring Low flow supplemental oxygen 5. Hospitalized, not requiring oxygen- but receiving ongoing medical care (related or not related to COVID-19) 6. Hospitalized/not hospitalized, Requiring neither oxygen nor ongoing medical care (other than that specified in the the protocol for COVID-HIG adminstration) 7. Not hospitalized, discharge or prepare for discharge from a healthcare facility

  within 28 days

Secondary Outcomes (12)

• Changes of 7-point ordinal scale for COVID-19 clinical improvement

  7 days, 14 days, and 28 days

• COVID-19-Related Symptoms

  1 day, 3 days, 5 days, 7 days and 14 days

• Discharge Status

  7 days, 14 days, and 28 days

• Length of hospital stay

  within 28 days

• All-cause Mortality

  within 28 days

Study Arms (3)

High Dose Group

EXPERIMENTAL

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.

Biological: Human COVID-19 immunoglobulin (pH4) for intravenous injection

Low Dose Group

EXPERIMENTAL

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.

Biological: Human COVID-19 immunoglobulin (pH4) for intravenous injection

Control Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Human COVID-19 immunoglobulin (pH4) for intravenous injection 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.

Also known as: COVID-HIG

High Dose Group; Low Dose Group

Placebo 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

Also known as: 0.9% sodium chloride injection

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 and \<65 years of age when signing the ICF, male or femal.
• Positive testing by virologic test (SARS-CoV-2 virus nucleic acid test,result of RT-PCR within 3 days are accpetable) before randomization.
• COVID-19 related clinical symptoms (fever or respiratory symptoms, etc.) progresses before randomization.
• Inpatients with moderate or severe COVID-19 (severity is graded by FDA standard).
• 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.
• Randomization should be within 10 days of COVID-19 symptoms onset.
• 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.
• 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.
• Able to consent, and willing to sign the ICF.

You may not qualify if:

• Asymptomatic infection, mild or critical COVID-19.
• SP02 \< 93% under high-flow oxygen inhalation, or receiving of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
• Reinfected subjects with historical confirmed COVID-19, detectable by SARS-CoV-2 serological test (nasopharyngeal SARS-CoV-2 RNA levels or serum antibody).
• May be transferred to another hospital, that is not one of the trial sites, within 72 hours.
• 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.
• History of allergic to IVIG, other plasma proteins or blood products, history of selective IgA deficiency with presence of anti-IgA antibodies.
• Vaccinated in last 8 weeks, such as influenza, poliomyelitis, measles, rubella, mumps and varicella virus vaccines.
• May worsen and progress to critical COVID-19 rapidly.
• Useage of other antiviral drugs to treat SARS-CoV-2 (except the basic treatment specified in the protocol) before randomization.
• 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.
• ALT or AST \> 2 times of the normal range upper limit, or Ccr \< 60 ml/min.
• 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.
• Positive of virues makers ( positive of HBsAg, HCV-Ab, or Treponema pallidum specific antibody).
• History of organ transplantation (such as heart, lung, liver, kidney, etc.
• Pregnant or lactating female.

Sponsors & Collaborators

• Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd.: lead
• China National Biotec Group Company Limited: collaborator
• Beijing Tiantan Biological Products Co., Ltd.: collaborator

Study Sites (1)

Al Rahba Hospital

Abu Dhabi, 51900, United Arab Emirates

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Nawal Al Kaabi, MBBA

  Sheikh Khalifa Medical City, SEHA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YunKai Yang, Prof

CONTACT

+86-13601126881; yangyunkai@sinopharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 30, 2021
• Study Start: December 30, 2021
• Primary Completion: June 20, 2023
• Study Completion: November 30, 2023
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)