Covid-19 Clinical Trial
Official title:
COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study
Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2. Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood. Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires as well as in form of interviews. Conclusion: This project will help obstetricians and neonatologists better recognize clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies alongside providing right level of surveillance and management during pregnancy, delivery, and child health care.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
| Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
| Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
| Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
| Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
| Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
| Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
| Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
| Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
| Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
| Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
| Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
| Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
| Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
| Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|