COVID-19Phase 4NCT04914832
Effectiveness of Covid-19 Vaccination in Eswatini Against SARS-CoV-2 Associated Hospitalization and Death
A Phase 4 study testing AZD1222 in people with COVID-19 and Pneumonia, Viral, run by Shabir Madhi at 1 site in Eswatini.
Trial summary
Since late December 2019, the novel human coronavirus (SARS-CoV-2) first reported in China, has spread worldwide. Vaccines to prevent SARS-CoV-2 infections have been developed in record time and several candidate vaccines have completed Phase 2a/b and Phase 3 clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pneumonia, Viral
- What is being tested?
- AZD1222
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75,012 participants
- Where
- 1 siteEswatini
- Study dates
- 30 Aug 2021to 30 Sep 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any individual aged 18 and older eligible to receive AZ1222 vaccine following the national immunization recommendations.
- Willing and able to provide informed consent.
- Ever eligible to receive AZ1222 vaccine following the national immunization recommendations prior to hospital admission.
- And
- Willing and able to provide informed consent.
Who cannot join
- Any significant acute or chronic medical condition that in the opinion of the vaccinator makes the participant unsuitable for participation in the study or jeopardises the safety of the participant.
- Participant reports being pregnant.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
- Test negative vaccine effectiveness case-control study
- The study population consists of individuals presenting at the participating hospitals and health centres during the study period, who:
- Either
Show all 11Show fewer
- Are hospitalized (or died) for an illness consistent with possible COVID-19. Or (in case of other hospital controls)
- Presented to the emergency department (ED) for reasons other than a COVID-19 like illness (e.g. trauma or elective surgery).
- And
- Meet the inclusion criteria.
- None
Trial locations and contacts
1 site in 1 country.
About this study
Since late December 2019, the novel human coronavirus (SARS-CoV-2) first reported in China, has spread worldwide. Vaccines to prevent SARS-CoV-2 infections have been developed in record time and several candidate vaccines have completed Phase 2a/b and Phase 3 clinical trials.
Coronaviruses (CoVs) are spherical, enveloped viruses with positive-sense single-stranded RNA genomes. One fourth of their genome is responsible for coding structural proteins, such as the Spike (S) glycoprotein, envelope, membrane, and nucleocapsid proteins. Envelope, membrane, and nucleocapsid proteins are mainly responsible for virion assembly whilst the S protein is involved in receptor binding, mediating virus entry into host cells during CoVs infection via different receptors. SARS-CoV-2 belongs to the phylogenetic lineage B of the genus Betacoronavirus and it recognizes the ACE2 as the entry receptor. It is the seventh CoV known to cause human infections and the third known to cause severe disease after SARS-CoV and MERS-CoV.
AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein. Development of AZD1222, previously referred to as ChAdOx1 nCoV-19, was initiated by the University of Oxford, UK, with subsequent transfer of development activities to AstraZeneca. The ChAdOx1 platform has been used in 14 clinical studies sponsored by the University of Oxford with immunogens from multiple pathogens such as influenza, tuberculosis, malaria, chikungunya, Zika, MERS-CoV, and Meningitis B. Over 360 healthy adult participants have received ChAdOx1-vectored vaccines in these studies. These vaccines demonstrated robust immunogenicity after a single dose and favourable safety profiles, with no vaccine-related serious adverse events (SAEs).
Read the detailed description
This will be open-label, single-arm implementation study in Eswatini. All individuals who register on the National Vaccination Registry will be eligible for enrolment. Participants will receive appointments for vaccination using the registry. Vaccination will be overseen by trained personnel. At enrolment participants will receive an intramuscular injection of AZ1222, a second dose will be given 10 weeks after the first injection. Surveillance for vaccine effectiveness will be performed at designated hospitals.
A prospective hospital-based, case-control study with test-negative controls (test-negative case-control design) and optionally other hospital controls (standard case-control design) will be conducted in parallel with the implementation study. Data will be collected through a network of hospitals located in Eswatini. A hospital-based case control study is an efficient design well suited to study for effectiveness against severe disease, and potentially allows for detailed medical information and additional data collection directly from the patient or healthcare provider. In addition, the study aims to determine the vaccine effectiveness (VE) of AZ1222 against severe disease due to the B.1.351 variant circulating in Southern Africa and other new variants that might evolve.
- Conditions
- COVID-19, Pneumonia, Viral
- Being tested
- AZD1222
- Keywords
- Vaccine, Effectiveness, COVID-19, pneumonia
- Medical subject headings
- COVID-19, Pneumonia, Viral, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1222Biological
AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein.
| Study group | Role | What they receive |
|---|---|---|
| All individuals who register on the National Vaccination Registry | Experimental | This will be open-label, single-arm implementation study in Eswatini. All individuals who register on the National Vaccination Registry will be eligible for enrolment. Participants will receive appointments for vaccination using the registry. Receives: Biological: AZD1222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV-uninfected patients with laboratory-confirmed SARS-CoV-2 illness
Laboratory-confirmed SARS-CoV-2 illness (COVID-19) hospitalizations and deaths in HIV-uninfected individuals who have been vaccinated with at least 1 dose.
Measured: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness who have been vaccinated with at least one dose
Laboratory-confirmed COVID-19 hospitalizations and deaths in individuals irrespective of HIV status [people living with (PLWH) and without HIV] who have been vaccinated with at least 1 dose.
Measured: 1 year
Secondary outcomes (6)
Number of HIV-uninfected patients with laboratory-confirmed SAR-CoV-2 illness
Laboratory-confirmed COVID-19 hospitalizations and deaths in HIV-uninfected individuals who have been fully vaccinated according to the national immunization recommendations.
Measured: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness who have been fully vaccinated
Laboratory-confirmed COVID-19 hospitalizations and deaths in individuals irrespective of HIV status who have been fully vaccinated according to the national immunization recommendations.
Measured: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness according to vaccination interval between doses
Laboratory-confirmed COVID-19 hospitalizations and deaths in individuals irrespective of HIV status who have been fully vaccinated according to the vaccine interval in between dose (≤4 weeks, 5-8 weeks, 8-11 weeks, ≥12 weeks).
Measured: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness by genetic variant
The effect of AZD1222 vaccine on laboratory-confirmed COVID-19 hospitalizations and deaths in individuals irrespective of HIV status who have been vaccinated (with at least 1 dose/ fully vaccinated according to the national recommendations), by viral genetic variants (particularly B.1.351 and non-B.1.351 variants).
Measured: 1 year
Number of patients of special interest with laboratory-confirmed SARS-CoV-2 illness
Laboratory-confirmed COVID-19 hospitalizations and deaths in individuals irrespective of HIV status who have been vaccinated (with at least 1 dose/ fully vaccinated according to the national recommendations), within populations of special interest (e.g. PLWH, specific age groups [special focus on the elderly], Chronic Respiratory Disease, Chronic Cardiovascular Disease, Chronic Kidney Disease, Chronic Liver Disease, Chronic neurologic Disease, Auto-Immune Disease, pregnant women, immunocompromised or specific chronic conditions).
Measured: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness by time since vaccination
The effect of AZD1222 vaccine against laboratory-confirmed COVID-19 hospitalization and death in individuals irrespective of HIV status who have been vaccinated (with at least 1 dose/ fully vaccinated according to the national recommendations), by time since vaccination, including ≤14 days prior to symptom onset.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start30 Aug 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1. Open-label, single-arm implementation study. 2. Prospective hospital and mortuary-based case-control study with test-negative controls (test-negative case-control study) and other hospital controls (standard case-control study).
- Masking
- None (open label)
- Enrolment
- 75,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shabir Madhi
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Shabir Madhi, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914832
- Sponsor's protocol ID
- Eswatini Implementation & VE
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2021
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20.
PubMed 32702298Greaney, A. J., A. N. Loes, K. H. D. Crawford, T. N. Starr, K. D. Malone, H. Y. Chu and J. D. Bloom (2021).
Tegally, H., E. Wilkinson, M. Giovanetti, A. Iranzadeh, V. Fonseca, J. Giandhari, D. Doolabh, S. Pillay, E. J. San, N. Msomi, K. Mlisana, A. von Gottberg, S. Walaza, M. Allam, A. Ismail, T. Mohale, A. J. Glass, S. Engelbrecht, G. Van Zyl, W. Preiser, F. Petruccione, A. Sigal, D. Hardie, G. Marais, M. Hsiao, S. Korsman, M.-A. Davies, L. Tyers, I. Mudau, D. York, C. Maslo, D. Goedhals, S. Abrahams, O. Laguda-Akingba, A. Alisoltani-Dehkordi, A. Godzik, C. K. Wibmer, B. T. Sewell, J. Lourenço, L. C. J. Alcantara, S. L. K. Pond, S. Weaver, D. Martin, R. J. Lessells, J. N. Bhiman, C. Williamson and T. de Oliveira (2020).
Volz, E., S. Mishra, M. Chand, J. C. Barrett, R. Johnson, L. Geidelberg, W. R. Hinsley, D. J. Laydon, G. Dabrera, Á. O'Toole, R. Amato, M. Ragonnet-Cronin, I. Harrison, B. Jackson, C. V. Ariani, O. Boyd, N. J. Loman, J. T. McCrone, S. Gonçalves, D. Jorgensen, R. Myers, V. Hill, D. K. Jackson, K. Gaythorpe, N. Groves, J. Sillitoe, D. P. Kwiatkowski, S. Flaxman, O. Ratmann, S. Bhatt, S. Hopkins, A. Gandy, A. Rambaut and N. M. Ferguson (2021).
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.
PubMed 33306989Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
PubMed 32015507Fischer, R. J., N. van Doremalen, D. R. Adney, C. K. Yinda, J. R. Port, M. G. Holbrook, J. E. Schulz, B. N. Williamson, T. Thomas, K. Barbian, S. L. Anzick, S. Ricklefs, B. J. Smith, D. Long, C. Martens, G. Saturday, E. de Wit, S. C. Gilbert, T. Lambe and V. J. Munster (2021).
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Covid-19 Vaccination in Eswatini Against SARS-CoV-2 Associated Hospitalization and Death
- ClinicalTrials.gov ID
- NCT04914832
- Acronym / sponsor ID
- Eswatini Implementation & VE
- Conditions
- COVID-19, Pneumonia, Viral
- Keywords
- Vaccine, Effectiveness, COVID-19, pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75,012 participants (actual)
- Lead sponsor
- Shabir MadhiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 Jun 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.
Since late December 2019, the novel human coronavirus (SARS-CoV-2) first reported in China, has spread worldwide. Vaccines to prevent SARS-CoV-2 infections have been developed in record time and several candidate vaccines have completed Phase 2a/b and Phase 3 clinical trials.
Coronaviruses (CoVs) are spherical, enveloped viruses with positive-sense single-stranded RNA genomes. One fourth of their genome is responsible for coding structural proteins, such as the Spike (S) glycoprotein, envelope, membrane, and nucleocapsid proteins. Envelope, membrane, and nucleocapsid proteins are mainly responsible for virion assembly whilst the S protein is involved in receptor binding, mediating virus entry into host cells during CoVs infection via different receptors. SARS-CoV-2 belongs to the phylogenetic lineage B of the genus Betacoronavirus and it recognizes the ACE2 as the entry receptor. It is the seventh CoV known to cause human infections and the third known to cause severe disease after SARS-CoV and MERS-CoV.
AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein. Development of AZD1222, previously referred to as ChAdOx1 nCoV-19, was initiated by the University of Oxford, UK, with subsequent transfer of development activities to AstraZeneca. The ChAdOx1 platform has been used in 14 clinical studies sponsored by the University of Oxford with immunogens from multiple pathogens such as influenza, tuberculosis, malaria, chikungunya, Zika, MERS-CoV, and Meningitis B. Over 360 healthy adult participants have received ChAdOx1-vectored vaccines in these studies. These vaccines demonstrated robust immunogenicity after a single dose and favourable safety profiles, with no vaccine-related serious adverse events (SAEs).
Detailed description
This will be open-label, single-arm implementation study in Eswatini. All individuals who register on the National Vaccination Registry will be eligible for enrolment. Participants will receive appointments for vaccination using the registry. Vaccination will be overseen by trained personnel. At enrolment participants will receive an intramuscular injection of AZ1222, a second dose will be given 10 weeks after the first injection. Surveillance for vaccine effectiveness will be performed at designated hospitals.
A prospective hospital-based, case-control study with test-negative controls (test-negative case-control design) and optionally other hospital controls (standard case-control design) will be conducted in parallel with the implementation study. Data will be collected through a network of hospitals located in Eswatini. A hospital-based case control study is an efficient design well suited to study for effectiveness against severe disease, and potentially allows for detailed medical information and additional data collection directly from the patient or healthcare provider. In addition, the study aims to determine the vaccine effectiveness (VE) of AZ1222 against severe disease due to the B.1.351 variant circulating in Southern Africa and other new variants that might evolve.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1. Open-label, single-arm implementation study. 2. Prospective hospital and mortuary-based case-control study with test-negative controls (test-negative case-control study) and other hospital controls (standard case-control study).
| Arm | Type | Receives |
|---|---|---|
| All individuals who register on the National Vaccination Registry | Experimental | Biological: AZD1222This will be open-label, single-arm implementation study in Eswatini. All individuals who register on the National Vaccination Registry will be eligible for enrolment. Participants will receive appointments for vaccination using the registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any individual aged 18 and older eligible to receive AZ1222 vaccine following the national immunization recommendations.
- Willing and able to provide informed consent.
- Ever eligible to receive AZ1222 vaccine following the national immunization recommendations prior to hospital admission.
- And
- Willing and able to provide informed consent.
Key exclusion criteria (11 listed)
- Any significant acute or chronic medical condition that in the opinion of the vaccinator makes the participant unsuitable for participation in the study or jeopardises the safety of the participant.
- Participant reports being pregnant.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
- Test negative vaccine effectiveness case-control study
- The study population consists of individuals presenting at the participating hospitals and health centres during the study period, who:
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 |
|---|---|---|
| AZD1222AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein. | Biological | All individuals who register on the National Vaccination Registry |
Primary outcome
Number of HIV-uninfected patients with laboratory-confirmed SARS-CoV-2 illness
Time frame: 1 year
Laboratory-confirmed SARS-CoV-2 illness (COVID-19) hospitalizations and deaths in HIV-uninfected individuals who have been vaccinated with at least 1 dose.
Number of patients with laboratory-confirmed SARS-CoV-2 illness who have been vaccinated with at least one dose
Time frame: 1 year
Laboratory-confirmed COVID-19 hospitalizations and deaths in individuals irrespective of HIV status [people living with (PLWH) and without HIV] who have been vaccinated with at least 1 dose.
6 secondary outcomes
Number of HIV-uninfected patients with laboratory-confirmed SAR-CoV-2 illness
Time frame: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness who have been fully vaccinated
Time frame: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness according to vaccination interval between doses
Time frame: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness by genetic variant
Time frame: 1 year
Number of patients of special interest with laboratory-confirmed SARS-CoV-2 illness
Time frame: 1 year
Number of patients with laboratory-confirmed SARS-CoV-2 illness by time since vaccination
Time frame: 1 year
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 29 Aug 2023.
- Background: PubMed 32702298Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20.
- BackgroundGreaney, A. J., A. N. Loes, K. H. D. Crawford, T. N. Starr, K. D. Malone, H. Y. Chu and J. D. Bloom (2021).
- BackgroundTegally, H., E. Wilkinson, M. Giovanetti, A. Iranzadeh, V. Fonseca, J. Giandhari, D. Doolabh, S. Pillay, E. J. San, N. Msomi, K. Mlisana, A. von Gottberg, S. Walaza, M. Allam, A. Ismail, T. Mohale, A. J. Glass, S. Engelbrecht, G. Van Zyl, W. Preiser, F. Petruccione, A. Sigal, D. Hardie, G. Marais, M. Hsiao, S. Korsman, M.-A. Davies, L. Tyers, I. Mudau, D. York, C. Maslo, D. Goedhals, S. Abrahams, O. Laguda-Akingba, A. Alisoltani-Dehkordi, A. Godzik, C. K. Wibmer, B. T. Sewell, J. Lourenço, L. C. J. Alcantara, S. L. K. Pond, S. Weaver, D. Martin, R. J. Lessells, J. N. Bhiman, C. Williamson and T. de Oliveira (2020).
- BackgroundVolz, E., S. Mishra, M. Chand, J. C. Barrett, R. Johnson, L. Geidelberg, W. R. Hinsley, D. J. Laydon, G. Dabrera, Á. O'Toole, R. Amato, M. Ragonnet-Cronin, I. Harrison, B. Jackson, C. V. Ariani, O. Boyd, N. J. Loman, J. T. McCrone, S. Gonçalves, D. Jorgensen, R. Myers, V. Hill, D. K. Jackson, K. Gaythorpe, N. Groves, J. Sillitoe, D. P. Kwiatkowski, S. Flaxman, O. Ratmann, S. Bhatt, S. Hopkins, A. Gandy, A. Rambaut and N. M. Ferguson (2021).
- Background: PubMed 33306989Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.
- Background: PubMed 32015507Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
- Results publicationFischer, R. J., N. van Doremalen, D. R. Adney, C. K. Yinda, J. R. Port, M. G. Holbrook, J. E. Schulz, B. N. Williamson, T. Thomas, K. Barbian, S. L. Anzick, S. Ricklefs, B. J. Smith, D. Long, C. Martens, G. Saturday, E. de Wit, S. C. Gilbert, T. Lambe and V. J. Munster (2021).
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AZD1222 in people with COVID-19 and Pneumonia, Viral, run by Shabir Madhi at 1 site in Eswatini.
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 5 inclusion and 11 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 29 Aug 2023. 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 Eswatini. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 HIV-uninfected patients with laboratory-confirmed SARS-CoV-2 illness (time frame: 1 year). 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 NCT04914832, which also lists 7 linked publications.
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 29 Aug 2023.