CoronavirusPhase 1NCT04816019
A Study of Intranasal ChAdOx1 nCOV-19
A Phase 1 study testing ChAdOx1 nCov-19 in people with Coronavirus, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Open label, dose escalation study to investigate: 1. Safety, tolerability and immunogenicity of one or two doses of intranasal ChAdOx1 nCOV-19, in vaccine naïve individuals, with randomisation between one and two dose groups. 2. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- ChAdOx1 nCov-19
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 30 Sep 2022
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Groups 1, 2 and 3 only: Healthy adults aged 18-55 years (Note, prior to implementation of SA001, a single participant under the age of 30 was enrolled in group 1a. This participant will be retained for follow-up but will not receive a booster vaccine, in light of the new age restrictions. Between the implementation of SA001 and implementation of SA003, only those aged 30-40 years were eligible.
- Groups 4 and 5 only: Healthy adults aged 30-55 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
- For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination.
- Agreement to refrain from blood donation during the course of the study.
Show all 17Show fewer
- Provide written informed consent.
- Group 4 only: Prior receipt of 2 doses of ChAdOx1 nCoV-19 intramuscularly, with an interval of at least 8 weeks between the intramuscular doses, and with the second dose a minimum of 12 weeks prior to enrolment
- Group 5 only: Prior receipt of 2 doses of BNT162b2 intramuscularly, with an interval of at least 3 weeks between the intramuscular doses, and with the second dose a minimum of 12 weeks prior to enrolment
- Acceptable forms of contraception for female volunteers include:
- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Total abdominal hysterectomy.
- Bilateral tubal Occlusion Barrier methods of contraception (condom or occlusive cap with spermicide).
- Male sterilisation, if the vasectomised partner is the sole partner for the subject.
- True abstinence, when this is in line with the preferred and usual lifestyle of the subject.
- Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception
Who cannot join
- Receipt or planned receipt of any vaccine other than the study intervention within 28 days before and after each study vaccination.
- Participation in COVID-19 prophylactic drug trials for the duration of the study. (Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The study team should be informed as soon as possible.)
- Groups 1, 2 and 3 only: Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days).
- Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy.
Show all 29Show fewer
- History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19.
- Any history of angioedema.
- Any history of anaphylaxis.
- Pregnancy, lactation or willingness/intention to become pregnant during the study.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of any organic central nervous system disorder or any functional disorder involving neurological symptoms
- History of serious psychiatric condition likely to affect participation in the study (e.g. ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture, or continuous anticoagulation e.g. with warfarin
- History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism), or
- History of antiphospholipid syndrome
- Prior receipt of unfractionated heparin
- History of heparin induced thrombocytopenia
- Any other serious chronic illness requiring hospital specialist supervision.
- Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed).
- Chronic cardiovascular disease (including hypertension), gastrointestinal disease, liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including diabetes) and neurological illness (excluding migraine).
- Nasal pathology (e.g. congenital abnormalities such as an abnormal septum or polyps, previous cauterisation, rhinoplasty or nasal surgery of any kind, recurrent epistaxis).
- Seriously overweight (BMI≥40 Kg/m2) or underweight (BMI≤18 Kg/m2).
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Any clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis.
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
- Groups 1, 2 and 3 only: Living in the same household as any vulnerable groups at risk of severe COVID-19 disease (as per PHE guidance).
- Groups 1, 2 and 3 only: Membership of any group identified by JCVI at the time of enrolment as being eligible for priority vaccination (i.e. ahead of the typical member of the individual's age cohort).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE
About this study
Official title: A Phase I Study to Determine Safety, Tolerability and Immunogenicity of Intranasal Administration of the COVID Vaccine ChAdOx1 nCOV-19 in Healthy UK Adults
Open label, dose escalation study to investigate:
- Safety, tolerability and immunogenicity of one or two doses of intranasal ChAdOx1 nCOV-19, in vaccine naïve individuals, with randomisation between one and two dose groups.
- Safety, tolerability and immunogenicity of intranasal ChAdOx1 nCOV-19, given as a booster dose in individuals who have had two intramuscular COVID-19 vaccinations.
Read the detailed description
The study will include up to 54 healthy adult participants, divided into five groups. Groups 1-3 will consist of vaccine-naïve volunteers and groups 4-5 will consist of volunteers who have received 2 doses of IM COVID-19 vaccine.
Groups 1-3 will receive three vaccine dose levels (low i.e. 5x10^9vp, high i.e. 5x10^10 VP, and moderate i.e. 2x10^10 VP ChAdOx1 nCOV-19 IN). The low and high dose groups will each have safety lead-in subgroups. All volunteers will be consented for receipt of a booster vaccine at approximately 4 weeks post first vaccine. All volunteers will be randomly allocated 1:1 to receive an intranasal booster vaccine as indicated, stratified by first dose level.
Group 4 will consist of volunteers who have received 2 intramuscular doses of ChAdOx1 nCoV-19, at least eight weeks apart, and group 5 will consist of volunteers who have received 2 intramuscular doses of BNT162b, at least three weeks apart. Both of these groups will receive a single standard dose (5x1010vp) on intranasal ChAdOx1 nCOV-19.
- Conditions
- Coronavirus
- Being tested
- ChAdOx1 nCov-19
- Keywords
- Covid-19, ChAdOx1 nCov19, SARS-CoV-2, Vaccine
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1 nCov-19Biological
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)
| Study group | Role | What they receive |
|---|---|---|
| Group 1a: Low Dose | Experimental | A single, Covid-19 vaccine naive volunteer will receive a single dose of 5x10^9vp ChAdOx1 nCOV-19 IN.
Volunteers in Group 1a \& b will be randomized to receive booster dose of 5 x 10^9vp ChAdOx1 IN or no booster Receives: Biological: ChAdOx1 nCov-19 |
| Group 1b: Low dose | Experimental | 5 Covid-19 vaccine naive volunteers will receive a single dose of 5x10^9vp ChAdOx1 nCOV-19 IN.
Volunteers in Group 1a \& b will be randomized to receive booster dose of 5 x 10^9vp ChAdOx1 IN or no booster Receives: Biological: ChAdOx1 nCov-19 |
| Group 2a: High Dose | Experimental | 3 Covid-19 vaccine naivevolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCOV-19 IN.
Volunteers in Group 2a \& b will be randomized to receive booster dose of 5 x 10^10vp ChAdOx1 IN or no booster Receives: Biological: ChAdOx1 nCov-19 |
| Group 2b: High Dose | Experimental | Up to 15 Covid-19 vaccine naive volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCOV-19 IN.
Volunteers in Group 2a \& b will be randomized to receive booster dose of 5 x 10^10vp ChAdOx1 IN or no booster Receives: Biological: ChAdOx1 nCov-19 |
| Group 3: Intermediate Dose | Experimental | Up to 18 Covid-19 vaccine naive volunteers will receive a single dose of 2x10^10vp ChAdOx1 nCOV-19 IN.
Volunteers will be randomized to receive booster dose of 2 x 10^10vp ChAdOx1 IN or no booster Receives: Biological: ChAdOx1 nCov-19 |
| Group 4: High Dose, vaccinated boost | Experimental | 6 volunteers, previously vaccinated with two doses of ChAdOx1 nCoV-19 IM will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 IN. Receives: Biological: ChAdOx1 nCov-19 |
| Group 5: High Dose, vaccinated boost | Experimental | 6 volunteers, previously vaccinated with two doses of BNT162b IM will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 IN. Receives: Biological: ChAdOx1 nCov-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms
Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination
Measured: 7 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Measured: 28 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of adverse events as identified by change in baseline safety laboratory measures
Change from baseline for safety laboratory measures (hematology and biochemistry) at Day 7 (and Day 35 for 2 dose groups only).
Safety laboratory measures include clinical blood tests for full blood count, liver function and renal function as graded on a predetermined toxicity grading scale.
Measured: 7 or 35 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs)
Occurrence of SAEs and AWESIs collected throughout the trial
Measured: 4 months
Secondary outcomes (1)
Assess the mucosal immune response to intranasal administration of one or two doses of ChAdOx1 nCov-19 in healthy adult volunteers
Quantification of spike-binding mucosal antibody, collected using SAM strips at D0, D7, D14, D28, D42 (2 dose groups only), D56, D112.
Includes characterisation of dose-response relationship
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Apr 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 (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Douglas, Dr, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816019
- Sponsor's protocol ID
- COV008
- Status last verified
- Nov 2021
- First submitted
- 15 Mar 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
PubMed 36435633
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine Safety, Tolerability and Immunogenicity of Intranasal Administration of the COVID Vaccine ChAdOx1 nCOV-19 in Healthy UK Adults
- ClinicalTrials.gov ID
- NCT04816019
- Acronym / sponsor ID
- COV008
- Conditions
- Coronavirus
- Keywords
- Covid-19, ChAdOx1 nCov19, SARS-CoV-2, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 25 Mar 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.
Open label, dose escalation study to investigate:
- Safety, tolerability and immunogenicity of one or two doses of intranasal ChAdOx1 nCOV-19, in vaccine naïve individuals, with randomisation between one and two dose groups.
- Safety, tolerability and immunogenicity of intranasal ChAdOx1 nCOV-19, given as a booster dose in individuals who have had two intramuscular COVID-19 vaccinations.
Detailed description
The study will include up to 54 healthy adult participants, divided into five groups. Groups 1-3 will consist of vaccine-naïve volunteers and groups 4-5 will consist of volunteers who have received 2 doses of IM COVID-19 vaccine.
Groups 1-3 will receive three vaccine dose levels (low i.e. 5x10^9vp, high i.e. 5x10^10 VP, and moderate i.e. 2x10^10 VP ChAdOx1 nCOV-19 IN). The low and high dose groups will each have safety lead-in subgroups. All volunteers will be consented for receipt of a booster vaccine at approximately 4 weeks post first vaccine. All volunteers will be randomly allocated 1:1 to receive an intranasal booster vaccine as indicated, stratified by first dose level.
Group 4 will consist of volunteers who have received 2 intramuscular doses of ChAdOx1 nCoV-19, at least eight weeks apart, and group 5 will consist of volunteers who have received 2 intramuscular doses of BNT162b, at least three weeks apart. Both of these groups will receive a single standard dose (5x1010vp) on intranasal ChAdOx1 nCOV-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1a: Low Dose | Experimental | Biological: ChAdOx1 nCov-19A single, Covid-19 vaccine naive volunteer will receive a single dose of 5x10^9vp ChAdOx1 nCOV-19 IN. Volunteers in Group 1a \& b will be randomized to receive booster dose of 5 x 10^9vp ChAdOx1 IN or no booster |
| Group 1b: Low dose | Experimental | Biological: ChAdOx1 nCov-195 Covid-19 vaccine naive volunteers will receive a single dose of 5x10^9vp ChAdOx1 nCOV-19 IN. Volunteers in Group 1a \& b will be randomized to receive booster dose of 5 x 10^9vp ChAdOx1 IN or no booster |
| Group 2a: High Dose | Experimental | Biological: ChAdOx1 nCov-193 Covid-19 vaccine naivevolunteers will receive a single dose of 5x10^10vp ChAdOx1 nCOV-19 IN. Volunteers in Group 2a \& b will be randomized to receive booster dose of 5 x 10^10vp ChAdOx1 IN or no booster |
| Group 2b: High Dose | Experimental | Biological: ChAdOx1 nCov-19Up to 15 Covid-19 vaccine naive volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCOV-19 IN. Volunteers in Group 2a \& b will be randomized to receive booster dose of 5 x 10^10vp ChAdOx1 IN or no booster |
| Group 3: Intermediate Dose | Experimental | Biological: ChAdOx1 nCov-19Up to 18 Covid-19 vaccine naive volunteers will receive a single dose of 2x10^10vp ChAdOx1 nCOV-19 IN. Volunteers will be randomized to receive booster dose of 2 x 10^10vp ChAdOx1 IN or no booster |
| Group 4: High Dose, vaccinated boost | Experimental | Biological: ChAdOx1 nCov-196 volunteers, previously vaccinated with two doses of ChAdOx1 nCoV-19 IM will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 IN. |
| Group 5: High Dose, vaccinated boost | Experimental | Biological: ChAdOx1 nCov-196 volunteers, previously vaccinated with two doses of BNT162b IM will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 IN. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Groups 1, 2 and 3 only: Healthy adults aged 18-55 years (Note, prior to implementation of SA001, a single participant under the age of 30 was enrolled in group 1a. This participant will be retained for follow-up but will not receive a booster vaccine, in light of the new age restrictions. Between the implementation of SA001 and implementation of SA003, only those aged 30-40 years were eligible.
- Groups 4 and 5 only: Healthy adults aged 30-55 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
- For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination.
Key exclusion criteria (29 listed)
- Receipt or planned receipt of any vaccine other than the study intervention within 28 days before and after each study vaccination.
- Participation in COVID-19 prophylactic drug trials for the duration of the study. (Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The study team should be informed as soon as possible.)
- Groups 1, 2 and 3 only: Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days).
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 |
|---|---|---|
| ChAdOx1 nCov-19A single dose of ChAdOx1 nCov-19 delivered intranasally (IN) | Biological | Group 1a: Low Dose, Group 1b: Low dose, Group 2a: High Dose, Group 2b: High Dose, Group 3: Intermediate Dose, Group 4: High Dose, vaccinated boost, Group 5: High Dose, vaccinated boost |
Primary outcome
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms
Time frame: 7 days
Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms
Time frame: 28 days
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of adverse events as identified by change in baseline safety laboratory measures
Time frame: 7 or 35 days
Change from baseline for safety laboratory measures (hematology and biochemistry) at Day 7 (and Day 35 for 2 dose groups only). Safety laboratory measures include clinical blood tests for full blood count, liver function and renal function as graded on a predetermined toxicity grading scale.
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs)
Time frame: 4 months
Occurrence of SAEs and AWESIs collected throughout the trial
1 secondary outcome
Assess the mucosal immune response to intranasal administration of one or two doses of ChAdOx1 nCov-19 in healthy adult volunteers
Time frame: 112 days
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 24 Oct 2022.
- Derived from this study: PubMed 36435633Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
Related trials for Coronavirus
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
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
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
Alexander Douglas, Dr principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAdOx1 nCov-19 in people with Coronavirus, run by University of Oxford at 1 site in United Kingdom.
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 17 inclusion and 29 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 24 Oct 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 Kingdom. 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 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?
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms (time frame: 7 days). The study lists 4 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 NCT04816019, 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 24 Oct 2022.