COVID-19Phase 2NCT05173441
Human COVID-19 Immunoglobulin (COVID-HIG) Therapy for COVID-19 Patients
A Phase 2 study testing Human COVID-19 immunoglobulin (pH4) for intravenous injection in people with COVID-19, run by Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd. at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Human COVID-19 immunoglobulin (pH4) for intravenous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 30 Dec 2021to 30 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- History of participated in other investigate drugs or medical devices clinical trials in last 1 month before signing ICF.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Al Rahba Hospital
Abu Dhabi, 51900
Nawal AI Kaabi, MBBA, +971505595521, nalkaabi@seha.ae
About this study
Official title: 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
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.
Read the 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
- Being tested
- Human COVID-19 immunoglobulin (pH4) for intravenous injection, Placebo
- Keywords
- COVID-19, immunoglobulin, COVID-HIG, SARS-CoV-2, 2019nCov, hyperimmune globulin, Coronavirus disease 2019, passive immunotherapy, therapeutic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human COVID-19 immunoglobulin (pH4) for intravenous injectionBiological
Also called COVID-HIG
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.
PlaceboDrug
Also called 0.9% sodium chloride 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Death
- Hospitalized, receiving Invasive mechanical ventilation or ECMO
- Hospitalized, receiving non-invasive ventilation or high-flow oxygen devices
- Hospitalized, requiring Low flow supplemental oxygen
- Hospitalized, not requiring oxygen- but receiving ongoing medical care (related or not related to COVID-19)
- Hospitalized/not hospitalized, Requiring neither oxygen nor ongoing medical care (other than that specified in the the protocol for COVID-HIG adminstration)
- Not hospitalized, discharge or prepare for discharge from a healthcare facility
Measured: within 28 days
Secondary outcomes (12)
Changes of 7-point ordinal scale for COVID-19 clinical improvement
Compare the clinical status of subjects in each group on day 7, 14, and 28 after the first administration using the primary 7-point ordinal outcome scale. Outcome is reported as the percent of subjects in each of 7 categories and changes in each group compared with baseline.
Measured: 7 days, 14 days, and 28 days
COVID-19-Related Symptoms
Outcome is reported as changes in each group compared with baseline.
Measured: 1 day, 3 days, 5 days, 7 days and 14 days
Discharge Status
Outcome is reported as the percent of subjects in each arm who discharged at day 7, 14, and 28 post treatment.
Measured: 7 days, 14 days, and 28 days
Length of hospital stay
Number of days between the first administration and discharge.
Measured: within 28 days
All-cause Mortality
Outcome is reported as the all-cause mortality within 28 days of each arm.
Measured: within 28 days
Negativization rate of SARS-CoV-2 nucleic acid
Outcome is reported as the percent of subjects with negative results in each arm.
Measured: within 72 hrs (24 hrs, 48 hrs, 72 hrs), 7 days, 14 days, and 28 days
Changes of leukocyte count, lymphocyte count, C-reactive protein, IL-6 and SARS-CoV-2 nucleic acid (quantitative)
Outcome is reported as the changes of leukocyte count, lymphocyte count, C-reactive protein, IL-6, and SARS-CoV-2 nucleic acid (quantitative) on 1day, 3days, 5days, 7 days, and 14 days commpared with baseline.
Measured: 1 day, 3 days, 5days, 7 days, 14 days
Treatment in ICU
The proportion and number of subjects who need treatment in ICU within 28 days after the first administration.
Measured: within 28 days
SARS-CoV-2 Neutralizing Antibody Level
Outcome reported as the changes in anti-SARS-CoV-2 neutralizing antibody titer in blood from baseline to 1 day, 3 days, 7 days, and 28 days post treatment. Outcome is reported in units of antibody titer.
Measured: 1 day, 3 days, 7 days, and 28 days
Glucocorticoid therapy
The proportion and the number of subjects receiving glucocorticoid therapy within 28 days after the first administration.
Measured: within 28 days
Rate of worsening
Worsening is defined as the 2 least favorable categories on the primary ordinal scale.
Outcome is reported as the percent of subjects in each arm who are characterized as worsening within 28 days post treatment.
Measured: within 28 days
Finger oxygen saturation
Change of finger oxygen saturation compared with the baseline.
Measured: 1 day, 3 days, 5 days, 7 days, 14 days, and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start30 Dec 2021 (estimated)
- Primary completion20 Jun 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China National Biotec Group Company Limited, Beijing Tiantan Biological Products Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Nawal Al Kaabi, MBBA, Principal investigator, Sheikh Khalifa Medical City, SEHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173441
- Sponsor's protocol ID
- COVID-19-IVIG-201
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05173441
- Acronym / sponsor ID
- COVID-19-IVIG-201
- Conditions
- COVID-19
- Keywords
- COVID-19, immunoglobulin, COVID-HIG, SARS-CoV-2, 2019nCov, hyperimmune globulin, Coronavirus disease 2019, passive immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- China National Biotec Group Company Limited, Beijing Tiantan Biological Products Co., Ltd.
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Group | Experimental | Biological: Human COVID-19 immunoglobulin (pH4) for intravenous injectionStandard 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. |
| Low Dose Group | Experimental | Biological: Human COVID-19 immunoglobulin (pH4) for intravenous injectionStandard 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. |
| Control Group | Placebo comparator | Drug: PlaceboStandard 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human COVID-19 immunoglobulin (pH4) for intravenous injectionAlso: COVID-HIGThe 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. | Biological | High Dose Group, Low Dose Group |
| PlaceboAlso: 0.9% sodium chloride injectionThe 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 | Drug | Control Group |
Primary outcome
Time to clinical improvement
Time frame: within 28 days
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
12 secondary outcomes
Changes of 7-point ordinal scale for COVID-19 clinical improvement
Time frame: 7 days, 14 days, and 28 days
COVID-19-Related Symptoms
Time frame: 1 day, 3 days, 5 days, 7 days and 14 days
Discharge Status
Time frame: 7 days, 14 days, and 28 days
Length of hospital stay
Time frame: within 28 days
All-cause Mortality
Time frame: within 28 days
Negativization rate of SARS-CoV-2 nucleic acid
Time frame: within 72 hrs (24 hrs, 48 hrs, 72 hrs), 7 days, 14 days, and 28 days
Changes of leukocyte count, lymphocyte count, C-reactive protein, IL-6 and SARS-CoV-2 nucleic acid (quantitative)
Time frame: 1 day, 3 days, 5days, 7 days, 14 days
Treatment in ICU
Time frame: within 28 days
SARS-CoV-2 Neutralizing Antibody Level
Time frame: 1 day, 3 days, 7 days, and 28 days
Glucocorticoid therapy
Time frame: within 28 days
Rate of worsening
Time frame: within 28 days
Finger oxygen saturation
Time frame: 1 day, 3 days, 5 days, 7 days, 14 days, and 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nawal Al Kaabi, MBBA principal investigator
Sheikh Khalifa Medical City, SEHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human COVID-19 immunoglobulin (pH4) for intravenous injection in people with COVID-19, run by Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd. at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YunKai Yang, Prof (+86-13601126881, yangyunkai@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement (time frame: within 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.