Covid19NCT04914013
Fugal Infection in COVID-19 Patients
An observational study of Covid19, run by Assiut University.
Trial summary
Screening early detection of invasive fungal sinusitis in COVID-19 positive patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Sep 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2. Patients were recruited from:1- Otorhinolaryngology Department, Assuit university hospital. 2- Intermediate care unit of Internal Medicine department. 3-Respiratory Intensive care unite and chest department.
Who may be able to join
- Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2.
Who cannot join
- - Patients who received antifungal therapy within three days prior to sample collection.
- Patients refused to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Invasive Fungal Sinusitis Among Post COVID-19 Survivors in Upper Egypt
Screening early detection of invasive fungal sinusitis in COVID-19 positive patients
Read the detailed description
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2); the causative organism of Coronavirus disease 2019 (Covid-19); infects primarily the lungs leading to more than 100 million COVID-19 cases around the world, resulting in almost three million deaths. Covid-19 spectrum of symptoms expanded from upper respiratory tract infection to extensive viral pneumonia and respiratory failure. Covid-19 patients are highly susceptible to superimposed secondary infection especially fungal infections.
Acute invasive fungal sinusitis (AIFS) is one of the most aggressive forms of sinusitis that is commonly present in immunocompromised patients and frequently leads to significant mortality and morbidity. Mucormycosis a life threatening AIFS characterized by hyphal invasion and massive destruction of maxillofacial structures. Histological characters include mycotic infiltration of vessels with propensity to tissue infarction. In addition to other fungi such as Acinetobacter, Klebsiella, Enterobacter, Aspergillus and Candida that frequently lead to secondary fungal infection in Covid-19 patients.
The co-existence of Covid-19 and AIFS is due to immune dysregulation in Covid-19 patients as both CD4+ and CD8+ T lymphocytes are suppressed thus impair patients' innate immunity. In addition to the extensive use of steroids, broad spectrum antibiotics and monoclonal antibodies may contribute in fungal infection. Covid-19 patients with pre-existing conditions such as untreated HIV, organ transplantation, un controlled diabetes and malignancies are more susceptible to AIFS on the contrary Covid-19 patients with underlying chronic disease such as hypertension, chronic kidney and chronic heart disease usually are not associated with more risk of AIFS.
Taking in consideration raised incidence of morbidity and mortality associated with AIFS and on the other hand limited studies available especially in middle east region raised the importance of studying the incidence and the behaviour of AIFS in Covid-19 patients. This study aims to To assess the occurrence of AIFS superinfections in patients with Covid-19.
- Conditions
- Covid19
- Being tested
- no intervention
- Keywords
- COVID-19, invasive fungal infection
- Medical subject headings
- COVID-19, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of invasive fungal sinusitis after covid 19 infection.
diagnosis of invasive fungal post COVID-19 infection
Measured: baseline
Secondary outcomes (1)
Identify specific fungi that participate in IFS
specify by culture and sensitivity fungi that participate in invasive fungal sinusitis after covid 19 infection
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maiada K. Hashem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914013
- Sponsor's protocol ID
- Fungi in COVID-19
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fekkar A, Lampros A, Mayaux J, Poignon C, Demeret S, Constantin JM, Marcelin AG, Monsel A, Luyt CE, Blaize M. Occurrence of Invasive Pulmonary Fungal Infections in Patients with Severe COVID-19 Admitted to the ICU. Am J Respir Crit Care Med. 2021 Feb 1;203(3):307-317. doi: 10.1164/rccm.202009-3400OC.
PubMed 33480831Sharma S, Grover M, Bhargava S, Samdani S, Kataria T. Post coronavirus disease mucormycosis: a deadly addition to the pandemic spectrum. J Laryngol Otol. 2021 May;135(5):442-447. doi: 10.1017/S0022215121000992. Epub 2021 Apr 8.
PubMed 33827722Alanio A, Delliere S, Fodil S, Bretagne S, Megarbane B. Prevalence of putative invasive pulmonary aspergillosis in critically ill patients with COVID-19. Lancet Respir Med. 2020 Jun;8(6):e48-e49. doi: 10.1016/S2213-2600(20)30237-X. Epub 2020 May 20. No abstract available.
PubMed 32445626
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Fungal Sinusitis Among Post COVID-19 Survivors in Upper Egypt
- ClinicalTrials.gov ID
- NCT04914013
- Acronym / sponsor ID
- Fungi in COVID-19
- Conditions
- Covid19
- Keywords
- COVID-19, invasive fungal infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 4 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.
Screening early detection of invasive fungal sinusitis in COVID-19 positive patients
Detailed description
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2); the causative organism of Coronavirus disease 2019 (Covid-19); infects primarily the lungs leading to more than 100 million COVID-19 cases around the world, resulting in almost three million deaths. Covid-19 spectrum of symptoms expanded from upper respiratory tract infection to extensive viral pneumonia and respiratory failure. Covid-19 patients are highly susceptible to superimposed secondary infection especially fungal infections.
Acute invasive fungal sinusitis (AIFS) is one of the most aggressive forms of sinusitis that is commonly present in immunocompromised patients and frequently leads to significant mortality and morbidity. Mucormycosis a life threatening AIFS characterized by hyphal invasion and massive destruction of maxillofacial structures. Histological characters include mycotic infiltration of vessels with propensity to tissue infarction. In addition to other fungi such as Acinetobacter, Klebsiella, Enterobacter, Aspergillus and Candida that frequently lead to secondary fungal infection in Covid-19 patients.
The co-existence of Covid-19 and AIFS is due to immune dysregulation in Covid-19 patients as both CD4+ and CD8+ T lymphocytes are suppressed thus impair patients' innate immunity. In addition to the extensive use of steroids, broad spectrum antibiotics and monoclonal antibodies may contribute in fungal infection. Covid-19 patients with pre-existing conditions such as untreated HIV, organ transplantation, un controlled diabetes and malignancies are more susceptible to AIFS on the contrary Covid-19 patients with underlying chronic disease such as hypertension, chronic kidney and chronic heart disease usually are not associated with more risk of AIFS.
Taking in consideration raised incidence of morbidity and mortality associated with AIFS and on the other hand limited studies available especially in middle east region raised the importance of studying the incidence and the behaviour of AIFS in Covid-19 patients. This study aims to To assess the occurrence of AIFS superinfections in patients with Covid-19.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2. Patients were recruited from:1- Otorhinolaryngology Department, Assuit university hospital. 2- Intermediate care unit of Internal Medicine department. 3-Respiratory Intensive care unite and chest department.
Key inclusion criteria (1 listed)
- Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2.
Key exclusion criteria (2 listed)
- - Patients who received antifungal therapy within three days prior to sample collection.
- Patients refused to participate in the study.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
detection of invasive fungal sinusitis after covid 19 infection.
Time frame: baseline
diagnosis of invasive fungal post COVID-19 infection
1 secondary outcome
Identify specific fungi that participate in IFS
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Background: PubMed 33480831Fekkar A, Lampros A, Mayaux J, Poignon C, Demeret S, Constantin JM, Marcelin AG, Monsel A, Luyt CE, Blaize M. Occurrence of Invasive Pulmonary Fungal Infections in Patients with Severe COVID-19 Admitted to the ICU. Am J Respir Crit Care Med. 2021 Feb 1;203(3):307-317. doi: 10.1164/rccm.202009-3400OC.
- Background: PubMed 33827722Sharma S, Grover M, Bhargava S, Samdani S, Kataria T. Post coronavirus disease mucormycosis: a deadly addition to the pandemic spectrum. J Laryngol Otol. 2021 May;135(5):442-447. doi: 10.1017/S0022215121000992. Epub 2021 Apr 8.
- Background: PubMed 32445626Alanio A, Delliere S, Fodil S, Bretagne S, Megarbane B. Prevalence of putative invasive pulmonary aspergillosis in critically ill patients with COVID-19. Lancet Respir Med. 2020 Jun;8(6):e48-e49. doi: 10.1016/S2213-2600(20)30237-X. Epub 2020 May 20. No abstract available.
Related trials for Covid19
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maiada Hashem (01006559662, maiada.hashem@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of invasive fungal sinusitis after covid 19 infection. (time frame: baseline). 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 NCT04914013, which also lists 3 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 4 Jun 2021.