CLINICAL TRIAL

AZD1222 for COVID-19

Waitlist Available · 18+ · All Sexes · North Charleston, SC

This study is evaluating whether a drug called AZD1222 can prevent COVID-19.

See full description

About the trial for COVID-19

Eligible Conditions
Coronavirus Disease 2019 (COVID‑19) · COVID-19

Treatment Groups

This trial involves 2 different treatments. AZD1222 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
AZD1222
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AstraZeneca COVID-19 Vaccine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Increased risk of SARS-CoV-2 infection
Medically stable
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether AZD1222 will improve 7 primary outcomes and 24 secondary outcomes in patients with COVID-19. Measurement will happen over the course of 7 days post each dose of study intervention..

The reactogenicity of 2 IM doses of AZD1222 compared to saline placebo (Substudy only)
7 DAYS POST EACH DOSE OF STUDY INTERVENTION.
Incidence of local and systemic solicited adverse events.
7 DAYS POST EACH DOSE OF STUDY INTERVENTION.
Anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only)
28 DAYS POST EACH DOSE
Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)
28 DAYS POST EACH DOSE
Antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only)
28 DAYS POST EACH DOSE
Post-treatment GMTs and GMFRs in SARS-CoV-2 S, RBD antibodies (MSD serology assay); The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay)
28 DAYS POST EACH DOSE
Number of Participants With Local and Systemic Solicited AEs in the Substudy Only
FROM DAY 1 UP TO 7 DAYS POST EACH DOSE OF STUDY INTERVENTION, APPROXIMATELY 14 DAYS
Solicited AEs are local or systemic predefined events for assessment of reactogenicity. Solicited AEs were collected in a e-Diary only for participants in the substudy.
FROM DAY 1 UP TO 7 DAYS POST EACH DOSE OF STUDY INTERVENTION, APPROXIMATELY 14 DAYS
Number of Participants With Adverse Events (AEs) Occurring Post Each Dose of Study Intervention
FROM DAY 1 UP TO 28 DAYS POST SECOND DOSE OF STUDY INTERVENTION, APPROXIMATELY 57 DAYS
An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
FROM DAY 1 UP TO 28 DAYS POST SECOND DOSE OF STUDY INTERVENTION, APPROXIMATELY 57 DAYS
The safety and tolerability of 2 IM doses of AZD1222 compared to saline placebo
A: 28 DAYS POST EACH DOSE OF STUDY INTERVENTION. / B: FROM DAY 1 POST-TREATMENT THROUGH DAY 730.
Incidence of adverse events. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.
A: 28 DAYS POST EACH DOSE OF STUDY INTERVENTION. / B: FROM DAY 1 POST-TREATMENT THROUGH DAY 730.
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for covid-19?

Many people affected by the coronavirus disease have access to non-pharmaceutical supportive interventions. These interventions include home treatment and self-care (e.g., handwashing), which can be improved by the provision of adequate supplies.

Anonymous Patient Answer

Can covid-19 be cured?

There are no known infectious agents that have been shown to cause clinical recovery. There is currently no evidence of a cure to the coronavirus disease 2019 (COVID-19). The case-fatality rate (CFR) has varied widely, and so far, in terms of the number of deaths, and the range has ranged from roughly 5% to around 43%. The most recent analysis predicts up to 60% fatalities in a developed country with a low-intensity, community spread pattern of transmission similar to that in European countries (i.e., where the transmission has been comparatively less severe).

Anonymous Patient Answer

How many people get covid-19 a year in the United States?

The number of new cases of COVID-19 per year estimated by the CDC as of 5 June 2020 is 6.1 cases per 100 000 persons of age (5.0 new cases per 100 000 persons of age, 95% confidence interval: 4.3 to 7.6; maximum likelihood estimate: 6.5 new cases per 100 000 persons of age, 95% lower limit: 3.2). About 2.5% (1.4% to 3.6%) of hospitalized patients and 2.3% (1.4% to 3.9%) of persons who died in those health care facilities had confirmed or probable COVID-19 infections.

Anonymous Patient Answer

What causes covid-19?

Age, sex, and race may be risk factors for severe and/or fatal outcomes of infected citizens in the United States. Preventative measures, such as limiting in-person social contacts with confirmed or suspected hospitalized cases, are recommended. Future studies on the clinical presentations are required to determine their impact on public health management and healthcare resource utilization.

Anonymous Patient Answer

What are the signs of covid-19?

There are several signs associated with the virus. Those include fever, cough, increased muscle and joint pains. Many people will also develop shortness of breath and a cough which is often dry or sticky in consistency.\n

Anonymous Patient Answer

What is covid-19?

The current report shows the impact of the outbreak on healthcare in the emergency department and the challenges faced when trying to mitigate the spread of the new coronavirus in an ever-changing clinical setting.

Anonymous Patient Answer

What are the common side effects of azd1222?

Overall, this study demonstrates that patients treated with AZD1222 at 20 mg/m2 experienced the highest rates of headache, dizziness, nausea, fatigue, constipation, decreased appetite and abdominal discomfort. As patients treated at higher doses of AZD1222 experienced an increase in dose-related hypersensitivity reactions and the highest rates of mild leukopenia, clinicians should consider administering AZD1222 at low doses at first and monitoring patients more often during the course of AZD1222 drug therapy.

Anonymous Patient Answer

Does azd1222 improve quality of life for those with covid-19?

Azd1222 for people with covid-19 and moderate-to-severe symptoms was well tolerated, had clinically meaningful effect on several domains of QoL, showed a rapid onset of treatment effects, and was well tolerated in a study with a small sample size. This proof-of-principle study demonstrates support for further investigation of AZD1222 in clinical populations. The clinical trial protocol for the study is available here: http://clinicaltrials.gov/ct2/show/NCT03074949.

Anonymous Patient Answer

Have there been other clinical trials involving azd1222?

[A Phase I/II clinical study of the immunoncologic drug azd1222 has been completed at our institution and has confirmed the preliminary safety profile seen in animal studies. Further investigation of this agent in the treatment of inflammatory conditions associated with a significant and progressive impairment of immune function is planned.

Anonymous Patient Answer

Have there been any new discoveries for treating covid-19?

There are also great advances for treating covid-19 by using lopinavir/ritonavir or chloroquine and/or azithromycin in addition to anti-viral drugs. We need a lot more research in this area. There are many unknown aspects for covid-19.

Anonymous Patient Answer

Has azd1222 proven to be more effective than a placebo?

In a recent study, findings confirm that it is safe to administer azd1222. The study suggests that azd1222 offers significant protection against moderate and severe pneumonia caused by SARS-CoV-2. In a recent study, findings is significant because there are no other vaccines that are ready for public use, and treatment options remain limited. The study also supports a potential role for SARS-CoV-2 vaccine development since it can provide significant protection in the event of a public health emergency.

Anonymous Patient Answer

Who should consider clinical trials for covid-19?

There is a high likelihood of a clinical trial being conducted as a response to the current outbreak of COVID-19; however, for both ethical and societal reasons, there is also a need to promote awareness of the potential benefits and harms of participating in such trials.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for COVID-19 by sharing your contact details with the study coordinator.