Saliva PCR in Pregnant Women with COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-10-07

Brief Summary

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Abstract: Objectives We aim to study the relative viral load using saliva polymerase chain reaction among pregnant women treated with Paxlovid. Methods Pregnant women with coronavirus disease 2019 were allocated to two groups: those receiving Paxlovid and those receiving no antiviral agents. We compared the nasopharyngeal and salivary relative viral loads and their changes in saliva specimens. Results Among the 38 pregnant women, seventeen received Paxlovid, and 21 received no antiviral agents. The viral cycle threshold value of saliva was significantly higher than that from nasopharynx, with a median ± interquartile range of 26.44 ± 7.68 versus 17.6 ± 9.6 in the Paxlovid group (p = 0.005). Following treatment, the Paxlovid group showed a significant decrease in relative saliva viral load (cycle threshold value on Day 4/Day 5 minus Day 0) compared to the non-antiviral group (13.40 ± 5.64 versus -1.59 ± 9.63, p = 0.021). The detection rate of coronavirus disease 2019 using salivary polymerase chain reaction was 81.6% (31/38). Conclusions This study showed that saliva is a useful diagnostic tool for coronavirus disease 2019 in pregnant women, and a significant decrease in the relative viral load of saliva was observed in those treated with Paxlovid.

Detailed Description

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Conditions

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Coronavirus Disease 2019 (COVID-19) Pneumonia

Keywords

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severe acute respiratory syndrome coronavirus 2; pregnancy; nirmatrelvir/ritonavir 25 (Paxlovid); saliva

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Nirmatrelvir/Ritonavir (Paxlovid)

After providing the potential benefits and associated risks of antiviral treatment with Paxlovid, patients made well-informed decisions about whether or not to receive Paxlovid (300/100 mg nirmatrelvir/ritonavir, Pfizer Inc., New York, NY, USA) twice daily for 5 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* This study enrolled pregnant women admitted to NCKUH 70 who tested positive for COVID-19 by real-time reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swab specimens. After providing the potential benefits and associated risks of antiviral treatment with Paxlovid, patients made a well-informed decision about whether or not to receive Paxlovid (300/100 mg nirmatrelvir/ritonavir, Pfizer Inc., USA) twice daily for 5 days.

Exclusion Criteria

* Pregnant women were excluded if the time interval between the onset of symptoms and admission to our hospital was greater than seven days, in the case of insufficient saliva samples, or if any antiviral-related agents were administered, such as remdesivir, glucocorticoids, or interleukin-6 receptor antagonists.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng 68 Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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IRB: B-ER-111-164

Identifier Type: -

Identifier Source: org_study_id