CoronaVirus Disease-2019 (COVID-19)Phase 1NCT04644120
Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19)
A Phase 1 study testing ABBV-47D11 and ABBV-2B04 in people with CoronaVirus Disease-2019 (COVID-19), run by AbbVie at 18 sites in 5 countries.
Trial summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CoronaVirus Disease-2019 (COVID-19)
- What is being tested?
- ABBV-47D11 and ABBV-2B04
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 10 Dec 2020to 24 Aug 2021
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization.
- Must have >= 1 symptom associated with COVID-19 with an onset of <= 8 days prior to randomization.
- Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study
Who cannot join
- Have an oxygen saturation (SpO2) < 88% on room air at rest for 5 minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <= 200 mmHg at randomization.
- Requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.
- Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States11 sites
Gadolin Research, LLC /ID# 229394
Beaumont, Texas, 77702-1100
University of Illinois Hospital and Health Sciences System /ID# 224323
Chicago, Illinois, 60612-7232
The Christ Hospital /ID# 224541
Cincinnati, Ohio, 45219
Beautiful Minds Clinical Research Center /ID# 228708
Cutler Bay, Florida, 33157-6608
Glendale Adventist Medical Center /ID# 225188
Glendale, California, 91206-4007
Prisma Health Children's Hospital Upstate /ID# 224556
Greenville, South Carolina, 29605-4210
University of Miami /ID# 225038
Miami, Florida, 33136
Saint Peter's University Hospital /ID# 225183
New Brunswick, New Jersey, 08901-1766
Saint Michael's Medical Center /ID# 225258
Newark, New Jersey, 07102
Pikeville Medical Center /ID# 224539
Pikeville, Kentucky, 41501-1689
Triple O Research Institute /ID# 228612
West Palm Beach, Florida, 33407-3100
Hungary2 sites
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015
Budapest, 1023
Semmelweis Egyetem /ID# 226016
Budapest, 1085
Israel2 sites
Hadassah Medical Center-Hebrew University /ID# 225827
Jerusalem, 91120
Sheba Medical Center /ID# 225857
Tel Hashomer, Ramat Gan, 52621
Puerto Rico2 sites
San Juan Bautista School of Medicine /ID# 225963
Caguas, 00726
Manati Medical Center /ID# 225936
Manati, 00674
Netherlands1 site
Universitair Medisch Centrum Utrecht /ID# 225919
Utrecht, 3584 CX
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 and ABBV-2B04 as Monotherapy or Combination Therapy in Adults With COVID-19
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug.
ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally.
Read more
In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
Read the detailed description
Part B of this study was not conducted.
- Conditions
- CoronaVirus Disease-2019 (COVID-19)
- Being tested
- ABBV-47D11, Placebo for ABBV-47D11, ABBV-2B04, Placebo for ABBV-2B04
- Keywords
- CoronaVirus Disease-2019, COVID-19, Severe Acute Respiratory Syndrome Coronavirus-2, SARS-CoV-2, ABBV-47D11, ABBV-2B04
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-47D11Drug
Intravenous (IV) infusion.
Placebo for ABBV-47D11Drug
Intravenous (IV) infusion.
ABBV-2B04Drug
Intervenous (IV) Infusion
Placebo for ABBV-2B04Drug
Intervenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A: Group 1: ABBV-47D11 Dose A | Experimental | Participants will receive ABBV-47D11 Dose A on Day 1. Receives: Drug: ABBV-47D11 |
| Part A: Group 1: Placebo for ABBV-47D11 | Placebo comparator | Participants will receive placebo for ABBV-47D11 on Day 1. Receives: Drug: Placebo for ABBV-47D11 |
| Part A: Group 2: ABBV-47D11 Dose B | Experimental | Participants will receive ABBV-47D11 Dose B on Day 1. Receives: Drug: ABBV-47D11 |
| Part A: Group 2: Placebo for ABBV-47D11 | Placebo comparator | Participants will receive placebo for ABBV-47D11 on Day 1. Receives: Drug: Placebo for ABBV-47D11 |
| Part A: Group 3: ABBV-47D11 Dose C | Experimental | Participants will receive ABBV-47D11 Dose C on Day 1. Receives: Drug: ABBV-47D11 |
| Part A: Group 3: Placebo for ABBV-47D11 | Placebo comparator | Participants will receive placebo for ABBV-47D11 on Day 1. Receives: Drug: Placebo for ABBV-47D11 |
| Part B: Group 1: ABBV-2B04 Dose A | Experimental | Participants will receive ABBV-2B04 Dose A on Day 1. Receives: Drug: ABBV-2B04 |
| Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11 | Experimental | Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1. Receives: Drug: ABBV-47D11; Drug: ABBV-2B04 |
| Part B: Group 1: Placebo | Placebo comparator | Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. Receives: Drug: Placebo for ABBV-47D11; Drug: Placebo for ABBV-2B04 |
| Part B: Group 2: ABBV-2B04 Dose B | Experimental | Participants will receive ABBV-2B04 Dose B on Day 1. Receives: Drug: ABBV-2B04 |
| Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11 | Experimental | Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1. Receives: Drug: ABBV-47D11; Drug: ABBV-2B04 |
| Part B: Group 2: Placebo | Placebo comparator | Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. Receives: Drug: Placebo for ABBV-47D11; Drug: Placebo for ABBV-2B04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
Measured: Up to Day 106
Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
Measured: Up to Day 106
Secondary outcomes (17)
Maximum Observed Serum Concentration (Cmax) of ABBV-47D11
Maximum observed serum concentration (Cmax) of ABBV-47D11.
Measured: Up to Day 85
Time to Cmax (Tmax) of ABBV-47D11
Time to maximum serum concentration of ABBV-47D11.
Measured: Up to Day 85
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11.
Measured: Up to Day 29
Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11
Terminal phase elimination half-life (t1/2) of ABBV-47D11.
Measured: Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.
Measured: Up to Day 85
Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11
Anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.
Measured: Up to Day 85
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11
Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.
Measured: Up to Day 85
AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.
Measured: Baseline (Day 1) through Day 29
Time to Negative SARS-CoV-2 by RT-PCR
Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.
Measured: Up to Day 29
Negative SARS-CoV-2 RNA by RT-PCR
Number of participants with negative SARS-CoV-2 RNA by RT-PCR.
Measured: Up to Day 15
Maximum Observed Serum Concentration (Cmax) of ABBV-2B04
Maximum observed serum concentration (Cmax) of ABBV-2B04.
Measured: Up to Day 85
Time to Cmax (Tmax) of ABBV-2B04
Time to maximum serum concentration of ABBV-2B04.
Measured: Up to Day 85
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04.
Measured: Up to Day 29
Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04
Terminal phase elimination half-life (t1/2) of ABBV-2B04.
Measured: Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04.
Measured: Up to Day 85
Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04
Anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.
Measured: Up to Day 85
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04
Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start10 Dec 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronaVirus Disease-2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644120
- Sponsor's protocol ID
- M20-404
- Other IDs
- 2020-005203-39
- Status last verified
- Aug 2021
- First submitted
- 23 Nov 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 and ABBV-2B04 as Monotherapy or Combination Therapy in Adults With COVID-19
- ClinicalTrials.gov ID
- NCT04644120
- Acronym / sponsor ID
- M20-404
- Conditions
- CoronaVirus Disease-2019 (COVID-19)
- Keywords
- CoronaVirus Disease-2019, COVID-19, Severe Acute Respiratory Syndrome Coronavirus-2, SARS-CoV-2, ABBV-47D11, ABBV-2B04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 25 Nov 2020 (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.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug.
ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally.
In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
Detailed description
Part B of this study was not conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A: Group 1: ABBV-47D11 Dose A | Experimental | Drug: ABBV-47D11Participants will receive ABBV-47D11 Dose A on Day 1. |
| Part A: Group 1: Placebo for ABBV-47D11 | Placebo comparator | Drug: Placebo for ABBV-47D11Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part A: Group 2: ABBV-47D11 Dose B | Experimental | Drug: ABBV-47D11Participants will receive ABBV-47D11 Dose B on Day 1. |
| Part A: Group 2: Placebo for ABBV-47D11 | Placebo comparator | Drug: Placebo for ABBV-47D11Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part A: Group 3: ABBV-47D11 Dose C | Experimental | Drug: ABBV-47D11Participants will receive ABBV-47D11 Dose C on Day 1. |
| Part A: Group 3: Placebo for ABBV-47D11 | Placebo comparator | Drug: Placebo for ABBV-47D11Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part B: Group 1: ABBV-2B04 Dose A | Experimental | Drug: ABBV-2B04Participants will receive ABBV-2B04 Dose A on Day 1. |
| Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11 | Experimental | Drug: ABBV-47D11, Drug: ABBV-2B04Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1. |
| Part B: Group 1: Placebo | Placebo comparator | Drug: Placebo for ABBV-47D11, Drug: Placebo for ABBV-2B04Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. |
| Part B: Group 2: ABBV-2B04 Dose B | Experimental | Drug: ABBV-2B04Participants will receive ABBV-2B04 Dose B on Day 1. |
| Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11 | Experimental | Drug: ABBV-47D11, Drug: ABBV-2B04Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1. |
| Part B: Group 2: Placebo | Placebo comparator | Drug: Placebo for ABBV-47D11, Drug: Placebo for ABBV-2B04Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization.
- Must have >= 1 symptom associated with COVID-19 with an onset of <= 8 days prior to randomization.
- Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study
Key exclusion criteria (3 listed)
- Have an oxygen saturation (SpO2) < 88% on room air at rest for 5 minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <= 200 mmHg at randomization.
- Requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.
- Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.
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 |
|---|---|---|
| ABBV-47D11Intravenous (IV) infusion. | Drug | Part A: Group 1: ABBV-47D11 Dose A, Part A: Group 2: ABBV-47D11 Dose B, Part A: Group 3: ABBV-47D11 Dose C, Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11, Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11 |
| Placebo for ABBV-47D11Intravenous (IV) infusion. | Drug | Part A: Group 1: Placebo for ABBV-47D11, Part A: Group 2: Placebo for ABBV-47D11, Part A: Group 3: Placebo for ABBV-47D11, Part B: Group 1: Placebo, Part B: Group 2: Placebo |
| ABBV-2B04Intervenous (IV) Infusion | Drug | Part B: Group 1: ABBV-2B04 Dose A, Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11, Part B: Group 2: ABBV-2B04 Dose B, Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11 |
| Placebo for ABBV-2B04Intervenous (IV) Infusion | Drug | Part B: Group 1: Placebo, Part B: Group 2: Placebo |
Primary outcome
Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)
Time frame: Up to Day 106
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions
Time frame: Up to Day 106
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
17 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of ABBV-47D11
Time frame: Up to Day 85
Time to Cmax (Tmax) of ABBV-47D11
Time frame: Up to Day 85
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11
Time frame: Up to Day 29
Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11
Time frame: Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11
Time frame: Up to Day 85
Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11
Time frame: Up to Day 85
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11
Time frame: Up to Day 85
AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Time frame: Baseline (Day 1) through Day 29
Time to Negative SARS-CoV-2 by RT-PCR
Time frame: Up to Day 29
Negative SARS-CoV-2 RNA by RT-PCR
Time frame: Up to Day 15
Maximum Observed Serum Concentration (Cmax) of ABBV-2B04
Time frame: Up to Day 85
Time to Cmax (Tmax) of ABBV-2B04
Time frame: Up to Day 85
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04
Time frame: Up to Day 29
Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04
Time frame: Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04
Time frame: Up to Day 85
Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04
Time frame: Up to Day 85
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04
Time frame: Up to Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- 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.
ABBVIE INC. study director
AbbVie
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-47D11 and ABBV-2B04 in people with CoronaVirus Disease-2019 (COVID-19), run by AbbVie at 18 sites in 5 countries.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Hungary, Israel, Puerto Rico, Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs) (time frame: Up to Day 106). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04644120, which also lists 1 linked publication.
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 2 Sep 2021.