SARS CoV 2 InfectionCOVID-TMMNCT05973084
COVID-19 Transmission and Morbidity in Malawi
An observational study of SARS CoV 2 Infection and SARS CoV 2 Vaccination, run by Boston University at 2 sites in 2 countries.
Trial summary
SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- SARS CoV 2 Infection, SARS CoV 2 Vaccination
- Type of treatment
- Vaccines
- How many people
- 1,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Jan 2023to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will take place in Blantyre, in one or all of the following health centers and their catchment areas: Bangwe, Chileka, Chilomoni, and Mpemba. These health centers were chosen because transmission of SARS-CoV-2 and malaria were recorded in their catchment area in the past two years. If needed, to reach the recruitment target, different health services in Blantyre may be considered for this research.
Who may be able to join
- Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test;
- Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers for the following 6 months;
- Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age;
- Has not received a SARS-CoV-2 vaccine in the previous 3 months
- Willingness to comply with study procedures and visits, and provides informed consent.
- Household Contacts of the Confirmed SARS-CoV-2 Case
Show all 12Show fewer
- Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers in the following 6 months;
- Willingness to comply with study procedures and follow-up visits and provides informed consent.
- Has not received a SARS-CoV-2 vaccine in the previous 3 months
- Vaccinees
- 1) Aged 18 years to 75 years; 2) Willingness to receive the primary regimen of the AZ and/or JJ vaccines 2) Not in the other 2 cohorts; 4) Willingness to comply with study procedures and follow-up visits and provides informed consent.
- 5) Has not received a prior dose of a SARS-CoV-2 vaccine
Who cannot join
- Conditions that precludes from adherence to the visit schedule;
- 50% or more of household members decline to participate.
- Pregnancy at the enrollment visit
- Long term use of cotrimoxazole prophylaxis
- Household Contacts of the Confirmed SARS-CoV-2 Case
- Conditions that preclude adherence to the visit schedule.
Show all 13Show fewer
- Participants with 2 consecutive negative SARS-CoV-2 RT-PCRs will be excluded from visits after M1.
- Pregnancy at the enrollment visit
- Long term use of cotrimoxazole prophylaxis
- Vaccinees
- Conditions that preclude adherence to the visit schedule.
- Pregnancy at the enrollment visit
- Long term use of cotrimoxazole prophylaxis
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
- Active, not recruiting
BU School of Public Health, Global Health Department
Boston, Massachusetts, 02118
Malawi1 site, 1 recruiting
- Recruiting
Health center
Blantyre
Don Mathanga, MBBS PhD
About this study
SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination.
Study objectives
- Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi
- Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses.
- Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections.
- Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination.
- Assess whether malaria and intestinal parasite infections, chronic/mild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism.
Read the detailed description
The investigators hypothesize that malaria and intestinal parasitic diseases may result in enhanced or tolerogenic innate immune responses that decrease the risk of symptomatic COVID-19. On the other hand, these conditions and deficiency of micronutrients may decrease the acquisition and longevity of antibodies induced by natural infection and SARS-CoV-2 vaccines, increasing the risk of re-infection and breakthrough infections to vaccination.
To test these hypotheses, up to 200 symptomatic individuals (index cases)will be enrolled, their household contacts (anticipated ~700), and up to 600 vaccinees. The specific innate immune phenotypes that differentiate uninfected Malawians from Western controls (based on samples from blood banks) and whether those responses are protecting Malawians from infection and/or progression of disease will be assessed. Infected participants and vaccinees will be followed for up to 1.5 years to assess acquisition and longevity of Ab responses and memory B cells.
- Conditions
- SARS CoV 2 Infection, SARS CoV 2 Vaccination
- Keywords
- Natural infection, Immune phenotypes, Innate immunity, SARS CoV 2 adaptive immunity, SARS CoV 2 antibody response, Vacinees, Household contacts, Malawi, Sub Saharan Africa
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Natural infection cohort | Up to 200 symptomatic subjects (index cases) will be enrolled when they seek diagnosis for their symptoms of COVID-19 and have their SARS-CoV-2 infection confirmed. All their household contacts (anticipated 700) aged 5-75 years who provide consent (participants) will be examined for infection through two consecutive SARS-CoV-2 RT-PCR. Blood will be drawn from all participants who provide consent. Venous Blood will be drawn at the first visit (so called W0). A second collection is planned for 15 days after the first visit, a third collection at three months after the first visit, and subsequent collections are planned at six, nine, and 15 months after the first visit. At the visits one month, nine months and 15 months after the first visit, capillary blood will be collected. A stool sample will be collected for diagnosis of intestinal parasites. | |
| Vaccine cohort | Up to 600 subjects 18-75 years will be recruited when they attend a vaccination clinic at one of the study health centers in Blantyre to receive their 1st dose of the AstraZeneca (AZ) or the Johnson and Johnson (JJ) COVID-19 vaccines. Venous blood will be collected at that time. For AZ vaccinees, at their 2nd vaccine dose, about 90 days after the 1st dose, they will be given a stool sample container. JJ vaccinees will receive the stool sample container when they receive the first vaccine dose. Two weeks after completion of the primary regimen (2nd dose of the AZ [M3.5] and 1st dose of the JJ vaccines [M0.5]), venous blood draws will be repeated and stool containers will be collected. Subsequent visits/procedures will happen at one month thereafter (M4.5 for AZ and M1.5 for JJ), and 3, 6, 9, and 12 months after the primary regimen. Venous blood will be collected at the visit 1.5, 3, 6, and 12 months after the primary regimen and capillary blood will be collected at the other visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of asymptomatic infection among contacts who acquire infection
Proportion of household members who acquire an asymptomatic (vs. symptomatic) infection among household contacts of an index case
Measured: up to 2 weeks
Duration of neutralizing antibody (NAb) responses against two viruses
Among participants who develop neutralizing antibody responses, days to decay antibody levels to a 25% level from baseline. NAbs levels, defined as dilution of serum or plasma required to inhibit 50% of virus entry into a target cell lines (ID50) will be measured against the vaccine matched viruses and an additional predominant circulating variant of concern at the time participant samples are collected.
Measured: up to 15 months
Change in frequencies of classical (CD14+CD16-) monocytes and markers of activation/inflammation with and without stimulation by by toll like receptor (TLR) and retinoic acid-inducible gene I (RIG-I) like receptors (RLR) ligands
Difference between measures obtained at 2 weeks and baseline in percentage positive. Percentage positive can range from 0 to 100. Change = Percentage positive at 2 weeks - Percentage positive at baseline
Measured: baseline, 2 weeks
Secondary outcomes (12)
Probably of infections in a household
Estimated probability of infection among household contacts of an index case
Measured: up to 2 weeks
Duration of COVID-19 symptoms, reinfection rates, and breakthrough infection rates
Days to resolve symptoms in each symptomatic episode and number of confirmed SARS-CoV-2 infection through RT-PCR after a first infection or vaccination
Measured: up to 15 months
Change in activation status of monocytes and monocyte-derived macrophages (MDMs) with and without stimulation with TLR and RLR agonists in vitro
Percentage positive of activation markers (CD169, CD86, and CD80) will be quantified by flow cytometry and can range from 0 to 100 of percent positive cells. Change = Percentage positive of CD169, CD86, and CD80 at 2 weeks - Percentage positive at baseline
Measured: baseline, 2 weeks
Change in cell activation markers among stimulated and unstimulated classical monocytes and MDMs
Difference between measures obtained at 2 weeks and baseline in percentage positive of CD169, CD86 and CD80 expression will be measured quantified through flow cytometry. Change = Percentage positive of CD169, CD86, and CD80 at 2 weeks - Percentage positive at baseline
Measured: baseline, 2 weeks
Change in concentrations of pro-inflammatory cytokines and chemokines produced by classic monocytes and MDMs
Difference between measures obtained at 2 weeks and baseline in concentration (median fluorescence intensity (MFI)) from M0 to M2 of chemokines and cytokines (e.g., MCP-1, IFNα, IFNβ, IFNλ, IP-10, IL-6, and IL-1 β) quantified through Luminex-based assays
Measured: baseline, 2 weeks
Change in expression of 770 host response genes in classical monocytes and MDMs
Host gene expression will be quantitated through NanoString nCounter Infectious Disease Host Response Panel, focusing on Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) and Interferon regulatory factor 3 (IRF3)-controlled dependent transcripts. Changes in gene expression will be reported as fold increase at 2 weeks over that observed at baseline
Measured: baseline, 2 weeks
Antibody magnitude to 3 SARS-COV-2 antigens and 3 trimers
Concentration (in Optical Density) of Immunoglobulin G (IgG) against Spike (S) protein, Receptor binding domain (RBD), and Nucleocapsid based trimer (N trimers) based on the vaccine matched variant and two other circulating variants of concern will be measured by Enzyme Linked Immunosorbent Assay (ELISA))
Measured: up to 12 months and 18 months, depending on the cohort
NAb responses measured against 3 viruses and through a surrogate assay (sENAB)
Inhibition of binding by RBD to ACE2 (ID50) receptor by plasma antibodies using a plate based surrogate neutralization assay.
Measured: up to 12 months, 15 months
Fc-gamma receptors (FcγR) -II/III binding functional antibody activities
Binding activity (in Optical Density) of FcγR against S, RBD antigens based measured by plate-based assay
Measured: 1 month
Duration of antibody-dependent cellular cytotoxicity (ADCC) responses
Using fresh Natural Killer (NK) cells that were incubated with interleukin 2 (IL-2), the investigators will quantify CD107a expression (determined by flow cytometry) by Natural Killer cells after incubation with opsonized antigen-coated beads (S antigen). Percentage of NK cells positive for CD107a
Measured: up to 12 months
Magnitude of dimeric Immunoglobulin A (dIgA)
Binding activity (in Optical Density) of IgA against S, RBD antigens based measured by ELISA.
Measured: 1 month
Frequencies of B (S-antigen specific and total) and plasma cells, and innate immunity parameters
Proportion of B cells (S-antigen and total) and plasma cells as a percentage of total B cells and total lymphocytes and innate immune parameters as a percentage of total immune cells at 12 and 15 months. Possible units can range from 0 to 16. Proportions will be compared between different patient groups, for example percentage positive in malaria uninfected compared to percentage positive in malaria infected patients.
Measured: up to 12 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start17 Jan 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Kamuzu University of Health Sciences, Burnet Institute
- Responsible party
- Sponsor
- Investigators
- Clarissa Valim, MD ScD, Principal investigator, BU School of Public Health, Department of Global HealthDon Mathanga, MBBS PhD, Principal investigator, Kamuzu University of Health Sciences, Malaria Alert Center, MalawiPatricia Hibberd, MD PhD, Principal investigator, BU School of Public Health, Department of Global HealthJames Beeson, MBBS PhD, Principal investigator, Burnet Institute, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973084
- Sponsor's protocol ID
- H-42505
- Other IDs
- 1R01AI164686-01A1
- Acronym
- COVID-TMM
- Status last verified
- May 2026
- First submitted
- 31 Jul 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Transmission and Morbidity in Malawi
- ClinicalTrials.gov ID
- NCT05973084
- Acronym / sponsor ID
- COVID-TMM / H-42505
- Conditions
- SARS CoV 2 Infection, SARS CoV 2 Vaccination
- Keywords
- Natural infection, Immune phenotypes, Innate immunity, SARS CoV 2 adaptive immunity, SARS CoV 2 antibody response, Vacinees, Household contacts, Malawi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Kamuzu University of Health Sciences, Burnet Institute
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Aug 2023 (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.
SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination.
Study objectives
- Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi
- Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses.
- Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections.
- Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination.
- Assess whether malaria and intestinal parasite infections, chronic/mild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism.
Detailed description
The investigators hypothesize that malaria and intestinal parasitic diseases may result in enhanced or tolerogenic innate immune responses that decrease the risk of symptomatic COVID-19. On the other hand, these conditions and deficiency of micronutrients may decrease the acquisition and longevity of antibodies induced by natural infection and SARS-CoV-2 vaccines, increasing the risk of re-infection and breakthrough infections to vaccination.
To test these hypotheses, up to 200 symptomatic individuals (index cases)will be enrolled, their household contacts (anticipated ~700), and up to 600 vaccinees. The specific innate immune phenotypes that differentiate uninfected Malawians from Western controls (based on samples from blood banks) and whether those responses are protecting Malawians from infection and/or progression of disease will be assessed. Infected participants and vaccinees will be followed for up to 1.5 years to assess acquisition and longevity of Ab responses and memory B cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural infection cohort | – | –Up to 200 symptomatic subjects (index cases) will be enrolled when they seek diagnosis for their symptoms of COVID-19 and have their SARS-CoV-2 infection confirmed. All their household contacts (anticipated 700) aged 5-75 years who provide consent (participants) will be examined for infection through two consecutive SARS-CoV-2 RT-PCR. Blood will be drawn from all participants who provide consent. Venous Blood will be drawn at the first visit (so called W0). A second collection is planned for 15 days after the first visit, a third collection at three months after the first visit, and subsequent collections are planned at six, nine, and 15 months after the first visit. At the visits one month, nine months and 15 months after the first visit, capillary blood will be collected. A stool sample will be collected for diagnosis of intestinal parasites. |
| Vaccine cohort | – | –Up to 600 subjects 18-75 years will be recruited when they attend a vaccination clinic at one of the study health centers in Blantyre to receive their 1st dose of the AstraZeneca (AZ) or the Johnson and Johnson (JJ) COVID-19 vaccines. Venous blood will be collected at that time. For AZ vaccinees, at their 2nd vaccine dose, about 90 days after the 1st dose, they will be given a stool sample container. JJ vaccinees will receive the stool sample container when they receive the first vaccine dose. Two weeks after completion of the primary regimen (2nd dose of the AZ [M3.5] and 1st dose of the JJ vaccines [M0.5]), venous blood draws will be repeated and stool containers will be collected. Subsequent visits/procedures will happen at one month thereafter (M4.5 for AZ and M1.5 for JJ), and 3, 6, 9, and 12 months after the primary regimen. Venous blood will be collected at the visit 1.5, 3, 6, and 12 months after the primary regimen and capillary blood will be collected at the other visits. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will take place in Blantyre, in one or all of the following health centers and their catchment areas: Bangwe, Chileka, Chilomoni, and Mpemba. These health centers were chosen because transmission of SARS-CoV-2 and malaria were recorded in their catchment area in the past two years. If needed, to reach the recruitment target, different health services in Blantyre may be considered for this research.
Key inclusion criteria (12 listed)
- Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test;
- Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers for the following 6 months;
- Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age;
- Has not received a SARS-CoV-2 vaccine in the previous 3 months
- Willingness to comply with study procedures and visits, and provides informed consent.
Key exclusion criteria (13 listed)
- Conditions that precludes from adherence to the visit schedule;
- 50% or more of household members decline to participate.
- Pregnancy at the enrollment visit
- Long term use of cotrimoxazole prophylaxis
- Household Contacts of the Confirmed SARS-CoV-2 Case
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk of asymptomatic infection among contacts who acquire infection
Time frame: up to 2 weeks
Proportion of household members who acquire an asymptomatic (vs. symptomatic) infection among household contacts of an index case
Duration of neutralizing antibody (NAb) responses against two viruses
Time frame: up to 15 months
Among participants who develop neutralizing antibody responses, days to decay antibody levels to a 25% level from baseline. NAbs levels, defined as dilution of serum or plasma required to inhibit 50% of virus entry into a target cell lines (ID50) will be measured against the vaccine matched viruses and an additional predominant circulating variant of concern at the time participant samples are collected.
Change in frequencies of classical (CD14+CD16-) monocytes and markers of activation/inflammation with and without stimulation by by toll like receptor (TLR) and retinoic acid-inducible gene I (RIG-I) like receptors (RLR) ligands
Time frame: baseline, 2 weeks
Difference between measures obtained at 2 weeks and baseline in percentage positive. Percentage positive can range from 0 to 100. Change = Percentage positive at 2 weeks - Percentage positive at baseline
12 secondary outcomes
Probably of infections in a household
Time frame: up to 2 weeks
Duration of COVID-19 symptoms, reinfection rates, and breakthrough infection rates
Time frame: up to 15 months
Change in activation status of monocytes and monocyte-derived macrophages (MDMs) with and without stimulation with TLR and RLR agonists in vitro
Time frame: baseline, 2 weeks
Change in cell activation markers among stimulated and unstimulated classical monocytes and MDMs
Time frame: baseline, 2 weeks
Change in concentrations of pro-inflammatory cytokines and chemokines produced by classic monocytes and MDMs
Time frame: baseline, 2 weeks
Change in expression of 770 host response genes in classical monocytes and MDMs
Time frame: baseline, 2 weeks
Antibody magnitude to 3 SARS-COV-2 antigens and 3 trimers
Time frame: up to 12 months and 18 months, depending on the cohort
NAb responses measured against 3 viruses and through a surrogate assay (sENAB)
Time frame: up to 12 months, 15 months
Fc-gamma receptors (FcγR) -II/III binding functional antibody activities
Time frame: 1 month
Duration of antibody-dependent cellular cytotoxicity (ADCC) responses
Time frame: up to 12 months
Magnitude of dimeric Immunoglobulin A (dIgA)
Time frame: 1 month
Frequencies of B (S-antigen specific and total) and plasma cells, and innate immunity parameters
Time frame: up to 12 months, 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- 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.
Clarissa Valim, MD ScD principal investigator
BU School of Public Health, Department of Global Health
Don Mathanga, MBBS PhD principal investigator
Kamuzu University of Health Sciences, Malaria Alert Center, Malawi
Patricia Hibberd, MD PhD principal investigator
BU School of Public Health, Department of Global Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection and SARS CoV 2 Vaccination, run by Boston University at 2 sites in 2 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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Malawi. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clarissa Valim, MD ScD ((617) 414-1260, cvalim@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of asymptomatic infection among contacts who acquire infection (time frame: up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.